Radiofrequency Ablation Companies: карта Product/API, Lumex, LabEx и Medical Devices с предметным portfolio-fit

Полная версия 2026 v2: 71 компаний; для каждой показаны три слоя: Product/API, Instrumental и Medical Devices; Instrumental разделён на отдельные колонки Lumex и LabEx. Для 0 компаний добавлены отдельные предложения «Возможно, по публичному портфелю» с конкретными существующими utilities.

Компаний

Слоёв на компанию

Каталог

Версия

Компаний с публичной предметной привязкой

Предметных utility-привязок

Radiofrequency Ablation Companies: полная карта Product/API, Lumex, LabEx и Medical Devices

Карта показывает предполагаемое соответствие существующих FUZKK utilities для 71 компаний по направлению: RF generators, catheters, probes, sterile kits, software и electrical safety. Для каждой компании показаны три слоя: Product/API, Instrumental и Medical Devices; Instrumental представлен двумя отдельными колонками Lumex и LabEx.

Маппинг предварительный: он не утверждает наличие конкретного продукта, прибора или программной системы у компании. Перед пилотом проверяются реальный portfolio, площадка, метод и формат данных.

Открыть компактную версию Показать пакеты по тегу Medical Devices

71Компаний

3Групп

3Слоёв на компанию

2026 v2Версия

Три слоя FUZKK

Product / APIПродуктовые, API- и отраслевые проверки.

Global API & Biosimilars QC Suite

Lumex (Instrumental слой)Instrumental QC, расчёт и обработка данных приборов.

Lumex QC Suite

LabEx (Instrumental слой)Лабораторные методы, микробиология и общие QC workflows.

LabEx QC Suite

Medical DevicesDesign controls, risk, software, cybersecurity, sterilization и QMS.

Medical Devices / стандарты и lifecycle QC

Как читать предметные предложения

Жёлтый блок добавляется только при достаточно точной публичной привязке к препарату, изотопу, тесту, платформе или продуктовой линии и при наличии соответствующей существующей FUZKK utility. Слово «возможно» означает предварительный portfolio-based fit, а не подтверждение производства на конкретной площадке или использования FUZKK. Отсутствие жёлтого блока означает, что точной публичной привязки пока недостаточно либо в каталоге нет подходящей предметной utility.

Interventional, cardiac и surgical RF systems · 31 компаний

Компания	Product / API: базовые + возможно предметные	Lumex (Instrumental слой)	LabEx (Instrumental слой)	Medical Devices
1. Medtronic Предполагаемый fit по профилю группы	Базовые проверкиParticulate Contamination Checker Sterility Result Evaluator Bioburden Checker Extractables Leachables Risk Assessor	Polymer ID EVA Polymer ID Polyethylene Polymer ID Polypropylene AAS Glass Leachables Test	Package Integrity & Leak Test Quality Checker Particle Count Injection USP <788> Quality Checker Environmental Monitoring Cleanroom Quality Checker FTIR Identity Quality Checker	Design Control Compliance Checker Risk Management Report Completeness Checker Risk Control Traceability Checker Requirement Traceability Checker Process Validation Checker
2. Boston Scientific Предполагаемый fit по профилю группы	Базовые проверкиParticulate Contamination Checker Sterility Result Evaluator Bioburden Checker Extractables Leachables Risk Assessor	Polymer ID EVA Polymer ID Polyethylene Polymer ID Polypropylene AAS Glass Leachables Test	Package Integrity & Leak Test Quality Checker Particle Count Injection USP <788> Quality Checker Environmental Monitoring Cleanroom Quality Checker FTIR Identity Quality Checker	Design Control Compliance Checker Risk Management Report Completeness Checker Risk Control Traceability Checker Requirement Traceability Checker Process Validation Checker
3. Abbott Предполагаемый fit по профилю группы	Базовые проверкиParticulate Contamination Checker Sterility Result Evaluator Bioburden Checker Extractables Leachables Risk Assessor	Polymer ID EVA Polymer ID Polyethylene Polymer ID Polypropylene AAS Glass Leachables Test	Package Integrity & Leak Test Quality Checker Particle Count Injection USP <788> Quality Checker Environmental Monitoring Cleanroom Quality Checker FTIR Identity Quality Checker	Design Control Compliance Checker Risk Management Report Completeness Checker Risk Control Traceability Checker Requirement Traceability Checker Process Validation Checker
4. Johnson & Johnson MedTech / Biosense Webster Предполагаемый fit по профилю группы	Базовые проверкиParticulate Contamination Checker Sterility Result Evaluator Bioburden Checker Extractables Leachables Risk Assessor	Polymer ID EVA Polymer ID Polyethylene Polymer ID Polypropylene AAS Glass Leachables Test	Package Integrity & Leak Test Quality Checker Particle Count Injection USP <788> Quality Checker Environmental Monitoring Cleanroom Quality Checker FTIR Identity Quality Checker	Design Control Compliance Checker Risk Management Report Completeness Checker Risk Control Traceability Checker Requirement Traceability Checker Process Validation Checker
5. AtriCure Предполагаемый fit по профилю группы	Базовые проверкиParticulate Contamination Checker Sterility Result Evaluator Bioburden Checker Extractables Leachables Risk Assessor	Polymer ID EVA Polymer ID Polyethylene Polymer ID Polypropylene AAS Glass Leachables Test	Package Integrity & Leak Test Quality Checker Particle Count Injection USP <788> Quality Checker Environmental Monitoring Cleanroom Quality Checker FTIR Identity Quality Checker	Design Control Compliance Checker Risk Management Report Completeness Checker Risk Control Traceability Checker Requirement Traceability Checker Process Validation Checker
6. AngioDynamics Предполагаемый fit по профилю группы	Базовые проверкиParticulate Contamination Checker Sterility Result Evaluator Bioburden Checker Extractables Leachables Risk Assessor	Polymer ID EVA Polymer ID Polyethylene Polymer ID Polypropylene AAS Glass Leachables Test	Package Integrity & Leak Test Quality Checker Particle Count Injection USP <788> Quality Checker Environmental Monitoring Cleanroom Quality Checker FTIR Identity Quality Checker	Design Control Compliance Checker Risk Management Report Completeness Checker Risk Control Traceability Checker Requirement Traceability Checker Process Validation Checker
7. Stryker Предполагаемый fit по профилю группы	Базовые проверкиParticulate Contamination Checker Sterility Result Evaluator Bioburden Checker Extractables Leachables Risk Assessor	Polymer ID EVA Polymer ID Polyethylene Polymer ID Polypropylene AAS Glass Leachables Test	Package Integrity & Leak Test Quality Checker Particle Count Injection USP <788> Quality Checker Environmental Monitoring Cleanroom Quality Checker FTIR Identity Quality Checker	Design Control Compliance Checker Risk Management Report Completeness Checker Risk Control Traceability Checker Requirement Traceability Checker Process Validation Checker
8. Olympus Предполагаемый fit по профилю группы	Базовые проверкиParticulate Contamination Checker Sterility Result Evaluator Bioburden Checker Extractables Leachables Risk Assessor	Polymer ID EVA Polymer ID Polyethylene Polymer ID Polypropylene AAS Glass Leachables Test	Package Integrity & Leak Test Quality Checker Particle Count Injection USP <788> Quality Checker Environmental Monitoring Cleanroom Quality Checker FTIR Identity Quality Checker	Design Control Compliance Checker Risk Management Report Completeness Checker Risk Control Traceability Checker Requirement Traceability Checker Process Validation Checker
9. Smith+Nephew Предполагаемый fit по профилю группы	Базовые проверкиParticulate Contamination Checker Sterility Result Evaluator Bioburden Checker Extractables Leachables Risk Assessor	Polymer ID EVA Polymer ID Polyethylene Polymer ID Polypropylene AAS Glass Leachables Test	Package Integrity & Leak Test Quality Checker Particle Count Injection USP <788> Quality Checker Environmental Monitoring Cleanroom Quality Checker FTIR Identity Quality Checker	Design Control Compliance Checker Risk Management Report Completeness Checker Risk Control Traceability Checker Requirement Traceability Checker Process Validation Checker
10. Avanos Medical Предполагаемый fit по профилю группы	Базовые проверкиParticulate Contamination Checker Sterility Result Evaluator Bioburden Checker Extractables Leachables Risk Assessor	Polymer ID EVA Polymer ID Polyethylene Polymer ID Polypropylene AAS Glass Leachables Test	Package Integrity & Leak Test Quality Checker Particle Count Injection USP <788> Quality Checker Environmental Monitoring Cleanroom Quality Checker FTIR Identity Quality Checker	Design Control Compliance Checker Risk Management Report Completeness Checker Risk Control Traceability Checker Requirement Traceability Checker Process Validation Checker
11. Merit Medical Systems Предполагаемый fit по профилю группы	Базовые проверкиParticulate Contamination Checker Sterility Result Evaluator Bioburden Checker Extractables Leachables Risk Assessor	Polymer ID EVA Polymer ID Polyethylene Polymer ID Polypropylene AAS Glass Leachables Test	Package Integrity & Leak Test Quality Checker Particle Count Injection USP <788> Quality Checker Environmental Monitoring Cleanroom Quality Checker FTIR Identity Quality Checker	Design Control Compliance Checker Risk Management Report Completeness Checker Risk Control Traceability Checker Requirement Traceability Checker Process Validation Checker
12. Hologic Предполагаемый fit по профилю группы	Базовые проверкиParticulate Contamination Checker Sterility Result Evaluator Bioburden Checker Extractables Leachables Risk Assessor	Polymer ID EVA Polymer ID Polyethylene Polymer ID Polypropylene AAS Glass Leachables Test	Package Integrity & Leak Test Quality Checker Particle Count Injection USP <788> Quality Checker Environmental Monitoring Cleanroom Quality Checker FTIR Identity Quality Checker	Design Control Compliance Checker Risk Management Report Completeness Checker Risk Control Traceability Checker Requirement Traceability Checker Process Validation Checker
13. Baylis Medical Technologies / Boston Scientific Предполагаемый fit по профилю группы	Базовые проверкиParticulate Contamination Checker Sterility Result Evaluator Bioburden Checker Extractables Leachables Risk Assessor	Polymer ID EVA Polymer ID Polyethylene Polymer ID Polypropylene AAS Glass Leachables Test	Package Integrity & Leak Test Quality Checker Particle Count Injection USP <788> Quality Checker Environmental Monitoring Cleanroom Quality Checker FTIR Identity Quality Checker	Design Control Compliance Checker Risk Management Report Completeness Checker Risk Control Traceability Checker Requirement Traceability Checker Process Validation Checker
14. CONMED Предполагаемый fit по профилю группы	Базовые проверкиParticulate Contamination Checker Sterility Result Evaluator Bioburden Checker Extractables Leachables Risk Assessor	Polymer ID EVA Polymer ID Polyethylene Polymer ID Polypropylene AAS Glass Leachables Test	Package Integrity & Leak Test Quality Checker Particle Count Injection USP <788> Quality Checker Environmental Monitoring Cleanroom Quality Checker FTIR Identity Quality Checker	Design Control Compliance Checker Risk Management Report Completeness Checker Risk Control Traceability Checker Requirement Traceability Checker Process Validation Checker
15. Ethicon Предполагаемый fit по профилю группы	Базовые проверкиParticulate Contamination Checker Sterility Result Evaluator Bioburden Checker Extractables Leachables Risk Assessor	Polymer ID EVA Polymer ID Polyethylene Polymer ID Polypropylene AAS Glass Leachables Test	Package Integrity & Leak Test Quality Checker Particle Count Injection USP <788> Quality Checker Environmental Monitoring Cleanroom Quality Checker FTIR Identity Quality Checker	Design Control Compliance Checker Risk Management Report Completeness Checker Risk Control Traceability Checker Requirement Traceability Checker Process Validation Checker
16. Erbe Elektromedizin Предполагаемый fit по профилю группы	Базовые проверкиParticulate Contamination Checker Sterility Result Evaluator Bioburden Checker Extractables Leachables Risk Assessor	Polymer ID EVA Polymer ID Polyethylene Polymer ID Polypropylene AAS Glass Leachables Test	Package Integrity & Leak Test Quality Checker Particle Count Injection USP <788> Quality Checker Environmental Monitoring Cleanroom Quality Checker FTIR Identity Quality Checker	Design Control Compliance Checker Risk Management Report Completeness Checker Risk Control Traceability Checker Requirement Traceability Checker Process Validation Checker
17. BOWA Medical Предполагаемый fit по профилю группы	Базовые проверкиParticulate Contamination Checker Sterility Result Evaluator Bioburden Checker Extractables Leachables Risk Assessor	Polymer ID EVA Polymer ID Polyethylene Polymer ID Polypropylene AAS Glass Leachables Test	Package Integrity & Leak Test Quality Checker Particle Count Injection USP <788> Quality Checker Environmental Monitoring Cleanroom Quality Checker FTIR Identity Quality Checker	Design Control Compliance Checker Risk Management Report Completeness Checker Risk Control Traceability Checker Requirement Traceability Checker Process Validation Checker
18. KLS Martin Предполагаемый fit по профилю группы	Базовые проверкиParticulate Contamination Checker Sterility Result Evaluator Bioburden Checker Extractables Leachables Risk Assessor	Polymer ID EVA Polymer ID Polyethylene Polymer ID Polypropylene AAS Glass Leachables Test	Package Integrity & Leak Test Quality Checker Particle Count Injection USP <788> Quality Checker Environmental Monitoring Cleanroom Quality Checker FTIR Identity Quality Checker	Design Control Compliance Checker Risk Management Report Completeness Checker Risk Control Traceability Checker Requirement Traceability Checker Process Validation Checker
19. Sutter Medizintechnik Предполагаемый fit по профилю группы	Базовые проверкиParticulate Contamination Checker Sterility Result Evaluator Bioburden Checker Extractables Leachables Risk Assessor	Polymer ID EVA Polymer ID Polyethylene Polymer ID Polypropylene AAS Glass Leachables Test	Package Integrity & Leak Test Quality Checker Particle Count Injection USP <788> Quality Checker Environmental Monitoring Cleanroom Quality Checker FTIR Identity Quality Checker	Design Control Compliance Checker Risk Management Report Completeness Checker Risk Control Traceability Checker Requirement Traceability Checker Process Validation Checker
20. inomed Medizintechnik Предполагаемый fit по профилю группы	Базовые проверкиParticulate Contamination Checker Sterility Result Evaluator Bioburden Checker Extractables Leachables Risk Assessor	Polymer ID EVA Polymer ID Polyethylene Polymer ID Polypropylene AAS Glass Leachables Test	Package Integrity & Leak Test Quality Checker Particle Count Injection USP <788> Quality Checker Environmental Monitoring Cleanroom Quality Checker FTIR Identity Quality Checker	Design Control Compliance Checker Risk Management Report Completeness Checker Risk Control Traceability Checker Requirement Traceability Checker Process Validation Checker
21. Diros Technology Предполагаемый fit по профилю группы	Базовые проверкиParticulate Contamination Checker Sterility Result Evaluator Bioburden Checker Extractables Leachables Risk Assessor	Polymer ID EVA Polymer ID Polyethylene Polymer ID Polypropylene AAS Glass Leachables Test	Package Integrity & Leak Test Quality Checker Particle Count Injection USP <788> Quality Checker Environmental Monitoring Cleanroom Quality Checker FTIR Identity Quality Checker	Design Control Compliance Checker Risk Management Report Completeness Checker Risk Control Traceability Checker Requirement Traceability Checker Process Validation Checker
22. Epimed Предполагаемый fit по профилю группы	Базовые проверкиParticulate Contamination Checker Sterility Result Evaluator Bioburden Checker Extractables Leachables Risk Assessor	Polymer ID EVA Polymer ID Polyethylene Polymer ID Polypropylene AAS Glass Leachables Test	Package Integrity & Leak Test Quality Checker Particle Count Injection USP <788> Quality Checker Environmental Monitoring Cleanroom Quality Checker FTIR Identity Quality Checker	Design Control Compliance Checker Risk Management Report Completeness Checker Risk Control Traceability Checker Requirement Traceability Checker Process Validation Checker
23. NeuroOne Medical Technologies Предполагаемый fit по профилю группы	Базовые проверкиParticulate Contamination Checker Sterility Result Evaluator Bioburden Checker Extractables Leachables Risk Assessor	Polymer ID EVA Polymer ID Polyethylene Polymer ID Polypropylene AAS Glass Leachables Test	Package Integrity & Leak Test Quality Checker Particle Count Injection USP <788> Quality Checker Environmental Monitoring Cleanroom Quality Checker FTIR Identity Quality Checker	Design Control Compliance Checker Risk Management Report Completeness Checker Risk Control Traceability Checker Requirement Traceability Checker Process Validation Checker
24. AtriAN Medical Предполагаемый fit по профилю группы	Базовые проверкиParticulate Contamination Checker Sterility Result Evaluator Bioburden Checker Extractables Leachables Risk Assessor	Polymer ID EVA Polymer ID Polyethylene Polymer ID Polypropylene AAS Glass Leachables Test	Package Integrity & Leak Test Quality Checker Particle Count Injection USP <788> Quality Checker Environmental Monitoring Cleanroom Quality Checker FTIR Identity Quality Checker	Design Control Compliance Checker Risk Management Report Completeness Checker Risk Control Traceability Checker Requirement Traceability Checker Process Validation Checker
25. Kardium Предполагаемый fit по профилю группы	Базовые проверкиParticulate Contamination Checker Sterility Result Evaluator Bioburden Checker Extractables Leachables Risk Assessor	Polymer ID EVA Polymer ID Polyethylene Polymer ID Polypropylene AAS Glass Leachables Test	Package Integrity & Leak Test Quality Checker Particle Count Injection USP <788> Quality Checker Environmental Monitoring Cleanroom Quality Checker FTIR Identity Quality Checker	Design Control Compliance Checker Risk Management Report Completeness Checker Risk Control Traceability Checker Requirement Traceability Checker Process Validation Checker
26. MicroPort EP MedTech Предполагаемый fit по профилю группы	Базовые проверкиParticulate Contamination Checker Sterility Result Evaluator Bioburden Checker Extractables Leachables Risk Assessor	Polymer ID EVA Polymer ID Polyethylene Polymer ID Polypropylene AAS Glass Leachables Test	Package Integrity & Leak Test Quality Checker Particle Count Injection USP <788> Quality Checker Environmental Monitoring Cleanroom Quality Checker FTIR Identity Quality Checker	Design Control Compliance Checker Risk Management Report Completeness Checker Risk Control Traceability Checker Requirement Traceability Checker Process Validation Checker
27. BIOTRONIK Предполагаемый fit по профилю группы	Базовые проверкиParticulate Contamination Checker Sterility Result Evaluator Bioburden Checker Extractables Leachables Risk Assessor	Polymer ID EVA Polymer ID Polyethylene Polymer ID Polypropylene AAS Glass Leachables Test	Package Integrity & Leak Test Quality Checker Particle Count Injection USP <788> Quality Checker Environmental Monitoring Cleanroom Quality Checker FTIR Identity Quality Checker	Design Control Compliance Checker Risk Management Report Completeness Checker Risk Control Traceability Checker Requirement Traceability Checker Process Validation Checker
28. Japan Lifeline Предполагаемый fit по профилю группы	Базовые проверкиParticulate Contamination Checker Sterility Result Evaluator Bioburden Checker Extractables Leachables Risk Assessor	Polymer ID EVA Polymer ID Polyethylene Polymer ID Polypropylene AAS Glass Leachables Test	Package Integrity & Leak Test Quality Checker Particle Count Injection USP <788> Quality Checker Environmental Monitoring Cleanroom Quality Checker FTIR Identity Quality Checker	Design Control Compliance Checker Risk Management Report Completeness Checker Risk Control Traceability Checker Requirement Traceability Checker Process Validation Checker
29. Osypka Medical Предполагаемый fit по профилю группы	Базовые проверкиParticulate Contamination Checker Sterility Result Evaluator Bioburden Checker Extractables Leachables Risk Assessor	Polymer ID EVA Polymer ID Polyethylene Polymer ID Polypropylene AAS Glass Leachables Test	Package Integrity & Leak Test Quality Checker Particle Count Injection USP <788> Quality Checker Environmental Monitoring Cleanroom Quality Checker FTIR Identity Quality Checker	Design Control Compliance Checker Risk Management Report Completeness Checker Risk Control Traceability Checker Requirement Traceability Checker Process Validation Checker
30. Lepu Medical Предполагаемый fit по профилю группы	Базовые проверкиParticulate Contamination Checker Sterility Result Evaluator Bioburden Checker Extractables Leachables Risk Assessor	Polymer ID EVA Polymer ID Polyethylene Polymer ID Polypropylene AAS Glass Leachables Test	Package Integrity & Leak Test Quality Checker Particle Count Injection USP <788> Quality Checker Environmental Monitoring Cleanroom Quality Checker FTIR Identity Quality Checker	Design Control Compliance Checker Risk Management Report Completeness Checker Risk Control Traceability Checker Requirement Traceability Checker Process Validation Checker
31. Lifetech Scientific Предполагаемый fit по профилю группы	Базовые проверкиParticulate Contamination Checker Sterility Result Evaluator Bioburden Checker Extractables Leachables Risk Assessor	Polymer ID EVA Polymer ID Polyethylene Polymer ID Polypropylene AAS Glass Leachables Test	Package Integrity & Leak Test Quality Checker Particle Count Injection USP <788> Quality Checker Environmental Monitoring Cleanroom Quality Checker FTIR Identity Quality Checker	Design Control Compliance Checker Risk Management Report Completeness Checker Risk Control Traceability Checker Requirement Traceability Checker Process Validation Checker

Tumour, pain и percutaneous ablation specialists · 20 компаний

Компания	Product / API: базовые + возможно предметные	Lumex (Instrumental слой)	LabEx (Instrumental слой)	Medical Devices
32. STARmed Предполагаемый fit по профилю группы	Базовые проверкиParticulate Contamination Checker Sterility Result Evaluator Bioburden Checker Extractables Leachables Risk Assessor	Polymer ID EVA Polymer ID Polyethylene Polymer ID Polypropylene AAS Glass Leachables Test	Package Integrity & Leak Test Quality Checker Particle Count Injection USP <788> Quality Checker Environmental Monitoring Cleanroom Quality Checker FTIR Identity Quality Checker	Design Control Compliance Checker Risk Management Report Completeness Checker Risk Control Traceability Checker Requirement Traceability Checker Process Validation Checker
33. RF Medical Предполагаемый fit по профилю группы	Базовые проверкиParticulate Contamination Checker Sterility Result Evaluator Bioburden Checker Extractables Leachables Risk Assessor	Polymer ID EVA Polymer ID Polyethylene Polymer ID Polypropylene AAS Glass Leachables Test	Package Integrity & Leak Test Quality Checker Particle Count Injection USP <788> Quality Checker Environmental Monitoring Cleanroom Quality Checker FTIR Identity Quality Checker	Design Control Compliance Checker Risk Management Report Completeness Checker Risk Control Traceability Checker Requirement Traceability Checker Process Validation Checker
34. Taewoong Medical Предполагаемый fit по профилю группы	Базовые проверкиParticulate Contamination Checker Sterility Result Evaluator Bioburden Checker Extractables Leachables Risk Assessor	Polymer ID EVA Polymer ID Polyethylene Polymer ID Polypropylene AAS Glass Leachables Test	Package Integrity & Leak Test Quality Checker Particle Count Injection USP <788> Quality Checker Environmental Monitoring Cleanroom Quality Checker FTIR Identity Quality Checker	Design Control Compliance Checker Risk Management Report Completeness Checker Risk Control Traceability Checker Requirement Traceability Checker Process Validation Checker
35. ECO Medical Предполагаемый fit по профилю группы	Базовые проверкиParticulate Contamination Checker Sterility Result Evaluator Bioburden Checker Extractables Leachables Risk Assessor	Polymer ID EVA Polymer ID Polyethylene Polymer ID Polypropylene AAS Glass Leachables Test	Package Integrity & Leak Test Quality Checker Particle Count Injection USP <788> Quality Checker Environmental Monitoring Cleanroom Quality Checker FTIR Identity Quality Checker	Design Control Compliance Checker Risk Management Report Completeness Checker Risk Control Traceability Checker Requirement Traceability Checker Process Validation Checker
36. Hangzhou Broncus Medical Предполагаемый fit по профилю группы	Базовые проверкиParticulate Contamination Checker Sterility Result Evaluator Bioburden Checker Extractables Leachables Risk Assessor	Polymer ID EVA Polymer ID Polyethylene Polymer ID Polypropylene AAS Glass Leachables Test	Package Integrity & Leak Test Quality Checker Particle Count Injection USP <788> Quality Checker Environmental Monitoring Cleanroom Quality Checker FTIR Identity Quality Checker	Design Control Compliance Checker Risk Management Report Completeness Checker Risk Control Traceability Checker Requirement Traceability Checker Process Validation Checker
37. Mermaid Medical Предполагаемый fit по профилю группы	Базовые проверкиParticulate Contamination Checker Sterility Result Evaluator Bioburden Checker Extractables Leachables Risk Assessor	Polymer ID EVA Polymer ID Polyethylene Polymer ID Polypropylene AAS Glass Leachables Test	Package Integrity & Leak Test Quality Checker Particle Count Injection USP <788> Quality Checker Environmental Monitoring Cleanroom Quality Checker FTIR Identity Quality Checker	Design Control Compliance Checker Risk Management Report Completeness Checker Risk Control Traceability Checker Requirement Traceability Checker Process Validation Checker
38. BVM Medical Предполагаемый fit по профилю группы	Базовые проверкиParticulate Contamination Checker Sterility Result Evaluator Bioburden Checker Extractables Leachables Risk Assessor	Polymer ID EVA Polymer ID Polyethylene Polymer ID Polypropylene AAS Glass Leachables Test	Package Integrity & Leak Test Quality Checker Particle Count Injection USP <788> Quality Checker Environmental Monitoring Cleanroom Quality Checker FTIR Identity Quality Checker	Design Control Compliance Checker Risk Management Report Completeness Checker Risk Control Traceability Checker Requirement Traceability Checker Process Validation Checker
39. APRO Korea Предполагаемый fit по профилю группы	Базовые проверкиParticulate Contamination Checker Sterility Result Evaluator Bioburden Checker Extractables Leachables Risk Assessor	Polymer ID EVA Polymer ID Polyethylene Polymer ID Polypropylene AAS Glass Leachables Test	Package Integrity & Leak Test Quality Checker Particle Count Injection USP <788> Quality Checker Environmental Monitoring Cleanroom Quality Checker FTIR Identity Quality Checker	Design Control Compliance Checker Risk Management Report Completeness Checker Risk Control Traceability Checker Requirement Traceability Checker Process Validation Checker
40. MedSphere International Предполагаемый fit по профилю группы	Базовые проверкиParticulate Contamination Checker Sterility Result Evaluator Bioburden Checker Extractables Leachables Risk Assessor	Polymer ID EVA Polymer ID Polyethylene Polymer ID Polypropylene AAS Glass Leachables Test	Package Integrity & Leak Test Quality Checker Particle Count Injection USP <788> Quality Checker Environmental Monitoring Cleanroom Quality Checker FTIR Identity Quality Checker	Design Control Compliance Checker Risk Management Report Completeness Checker Risk Control Traceability Checker Requirement Traceability Checker Process Validation Checker
41. Boston Scientific Cosman Предполагаемый fit по профилю группы	Базовые проверкиParticulate Contamination Checker Sterility Result Evaluator Bioburden Checker Extractables Leachables Risk Assessor	Polymer ID EVA Polymer ID Polyethylene Polymer ID Polypropylene AAS Glass Leachables Test	Package Integrity & Leak Test Quality Checker Particle Count Injection USP <788> Quality Checker Environmental Monitoring Cleanroom Quality Checker FTIR Identity Quality Checker	Design Control Compliance Checker Risk Management Report Completeness Checker Risk Control Traceability Checker Requirement Traceability Checker Process Validation Checker
42. Avanos COOLIEF Предполагаемый fit по профилю группы	Базовые проверкиParticulate Contamination Checker Sterility Result Evaluator Bioburden Checker Extractables Leachables Risk Assessor	Polymer ID EVA Polymer ID Polyethylene Polymer ID Polypropylene AAS Glass Leachables Test	Package Integrity & Leak Test Quality Checker Particle Count Injection USP <788> Quality Checker Environmental Monitoring Cleanroom Quality Checker FTIR Identity Quality Checker	Design Control Compliance Checker Risk Management Report Completeness Checker Risk Control Traceability Checker Requirement Traceability Checker Process Validation Checker
43. Integra NeuroSciences Предполагаемый fit по профилю группы	Базовые проверкиParticulate Contamination Checker Sterility Result Evaluator Bioburden Checker Extractables Leachables Risk Assessor	Polymer ID EVA Polymer ID Polyethylene Polymer ID Polypropylene AAS Glass Leachables Test	Package Integrity & Leak Test Quality Checker Particle Count Injection USP <788> Quality Checker Environmental Monitoring Cleanroom Quality Checker FTIR Identity Quality Checker	Design Control Compliance Checker Risk Management Report Completeness Checker Risk Control Traceability Checker Requirement Traceability Checker Process Validation Checker
44. Theraclion Предполагаемый fit по профилю группы	Базовые проверкиParticulate Contamination Checker Sterility Result Evaluator Bioburden Checker Extractables Leachables Risk Assessor	Polymer ID EVA Polymer ID Polyethylene Polymer ID Polypropylene AAS Glass Leachables Test	Package Integrity & Leak Test Quality Checker Particle Count Injection USP <788> Quality Checker Environmental Monitoring Cleanroom Quality Checker FTIR Identity Quality Checker	Design Control Compliance Checker Risk Management Report Completeness Checker Risk Control Traceability Checker Requirement Traceability Checker Process Validation Checker
45. Creo Medical Предполагаемый fit по профилю группы	Базовые проверкиParticulate Contamination Checker Sterility Result Evaluator Bioburden Checker Extractables Leachables Risk Assessor	Polymer ID EVA Polymer ID Polyethylene Polymer ID Polypropylene AAS Glass Leachables Test	Package Integrity & Leak Test Quality Checker Particle Count Injection USP <788> Quality Checker Environmental Monitoring Cleanroom Quality Checker FTIR Identity Quality Checker	Design Control Compliance Checker Risk Management Report Completeness Checker Risk Control Traceability Checker Requirement Traceability Checker Process Validation Checker
46. EMcision Предполагаемый fit по профилю группы	Базовые проверкиParticulate Contamination Checker Sterility Result Evaluator Bioburden Checker Extractables Leachables Risk Assessor	Polymer ID EVA Polymer ID Polyethylene Polymer ID Polypropylene AAS Glass Leachables Test	Package Integrity & Leak Test Quality Checker Particle Count Injection USP <788> Quality Checker Environmental Monitoring Cleanroom Quality Checker FTIR Identity Quality Checker	Design Control Compliance Checker Risk Management Report Completeness Checker Risk Control Traceability Checker Requirement Traceability Checker Process Validation Checker
47. AngioCare Предполагаемый fit по профилю группы	Базовые проверкиParticulate Contamination Checker Sterility Result Evaluator Bioburden Checker Extractables Leachables Risk Assessor	Polymer ID EVA Polymer ID Polyethylene Polymer ID Polypropylene AAS Glass Leachables Test	Package Integrity & Leak Test Quality Checker Particle Count Injection USP <788> Quality Checker Environmental Monitoring Cleanroom Quality Checker FTIR Identity Quality Checker	Design Control Compliance Checker Risk Management Report Completeness Checker Risk Control Traceability Checker Requirement Traceability Checker Process Validation Checker
48. MedWaves Предполагаемый fit по профилю группы	Базовые проверкиParticulate Contamination Checker Sterility Result Evaluator Bioburden Checker Extractables Leachables Risk Assessor	Polymer ID EVA Polymer ID Polyethylene Polymer ID Polypropylene AAS Glass Leachables Test	Package Integrity & Leak Test Quality Checker Particle Count Injection USP <788> Quality Checker Environmental Monitoring Cleanroom Quality Checker FTIR Identity Quality Checker	Design Control Compliance Checker Risk Management Report Completeness Checker Risk Control Traceability Checker Requirement Traceability Checker Process Validation Checker
49. NeuWave Medical / Johnson & Johnson Предполагаемый fit по профилю группы	Базовые проверкиParticulate Contamination Checker Sterility Result Evaluator Bioburden Checker Extractables Leachables Risk Assessor	Polymer ID EVA Polymer ID Polyethylene Polymer ID Polypropylene AAS Glass Leachables Test	Package Integrity & Leak Test Quality Checker Particle Count Injection USP <788> Quality Checker Environmental Monitoring Cleanroom Quality Checker FTIR Identity Quality Checker	Design Control Compliance Checker Risk Management Report Completeness Checker Risk Control Traceability Checker Requirement Traceability Checker Process Validation Checker
50. Vison Medical Предполагаемый fit по профилю группы	Базовые проверкиParticulate Contamination Checker Sterility Result Evaluator Bioburden Checker Extractables Leachables Risk Assessor	Polymer ID EVA Polymer ID Polyethylene Polymer ID Polypropylene AAS Glass Leachables Test	Package Integrity & Leak Test Quality Checker Particle Count Injection USP <788> Quality Checker Environmental Monitoring Cleanroom Quality Checker FTIR Identity Quality Checker	Design Control Compliance Checker Risk Management Report Completeness Checker Risk Control Traceability Checker Requirement Traceability Checker Process Validation Checker
51. Medtronic OsteoCool Предполагаемый fit по профилю группы	Базовые проверкиParticulate Contamination Checker Sterility Result Evaluator Bioburden Checker Extractables Leachables Risk Assessor	Polymer ID EVA Polymer ID Polyethylene Polymer ID Polypropylene AAS Glass Leachables Test	Package Integrity & Leak Test Quality Checker Particle Count Injection USP <788> Quality Checker Environmental Monitoring Cleanroom Quality Checker FTIR Identity Quality Checker	Design Control Compliance Checker Risk Management Report Completeness Checker Risk Control Traceability Checker Requirement Traceability Checker Process Validation Checker

Dermatology, aesthetic и energy-based RF platforms · 20 компаний

Компания	Product / API: базовые + возможно предметные	Lumex (Instrumental слой)	LabEx (Instrumental слой)	Medical Devices
52. InMode Предполагаемый fit по профилю группы	Базовые проверкиParticulate Contamination Checker Bioburden Checker Extractables Leachables Risk Assessor Sterility Result Evaluator	Polymer ID Polyethylene Polymer ID Polypropylene System Suitability Parameters Checker Polymer ID EVA	Package Integrity & Leak Test Quality Checker FTIR Identity Quality Checker Elemental Impurities ICP Quality Checker Particle Count Injection USP <788> Quality Checker	Electrical Safety Test Summary Checker EMCTest Coverage Checker Biocompatibility Gap Assessment Checker Software Safety Class Checker Design Control Compliance Checker
53. Alma Lasers Предполагаемый fit по профилю группы	Базовые проверкиParticulate Contamination Checker Bioburden Checker Extractables Leachables Risk Assessor Sterility Result Evaluator	Polymer ID Polyethylene Polymer ID Polypropylene System Suitability Parameters Checker Polymer ID EVA	Package Integrity & Leak Test Quality Checker FTIR Identity Quality Checker Elemental Impurities ICP Quality Checker Particle Count Injection USP <788> Quality Checker	Electrical Safety Test Summary Checker EMCTest Coverage Checker Biocompatibility Gap Assessment Checker Software Safety Class Checker Design Control Compliance Checker
54. Candela Medical Предполагаемый fit по профилю группы	Базовые проверкиParticulate Contamination Checker Bioburden Checker Extractables Leachables Risk Assessor Sterility Result Evaluator	Polymer ID Polyethylene Polymer ID Polypropylene System Suitability Parameters Checker Polymer ID EVA	Package Integrity & Leak Test Quality Checker FTIR Identity Quality Checker Elemental Impurities ICP Quality Checker Particle Count Injection USP <788> Quality Checker	Electrical Safety Test Summary Checker EMCTest Coverage Checker Biocompatibility Gap Assessment Checker Software Safety Class Checker Design Control Compliance Checker
55. Cynosure Lutronic Предполагаемый fit по профилю группы	Базовые проверкиParticulate Contamination Checker Bioburden Checker Extractables Leachables Risk Assessor Sterility Result Evaluator	Polymer ID Polyethylene Polymer ID Polypropylene System Suitability Parameters Checker Polymer ID EVA	Package Integrity & Leak Test Quality Checker FTIR Identity Quality Checker Elemental Impurities ICP Quality Checker Particle Count Injection USP <788> Quality Checker	Electrical Safety Test Summary Checker EMCTest Coverage Checker Biocompatibility Gap Assessment Checker Software Safety Class Checker Design Control Compliance Checker
56. Venus Concept Предполагаемый fit по профилю группы	Базовые проверкиParticulate Contamination Checker Bioburden Checker Extractables Leachables Risk Assessor Sterility Result Evaluator	Polymer ID Polyethylene Polymer ID Polypropylene System Suitability Parameters Checker Polymer ID EVA	Package Integrity & Leak Test Quality Checker FTIR Identity Quality Checker Elemental Impurities ICP Quality Checker Particle Count Injection USP <788> Quality Checker	Electrical Safety Test Summary Checker EMCTest Coverage Checker Biocompatibility Gap Assessment Checker Software Safety Class Checker Design Control Compliance Checker
57. Lumenis / Boston Scientific Предполагаемый fit по профилю группы	Базовые проверкиParticulate Contamination Checker Bioburden Checker Extractables Leachables Risk Assessor Sterility Result Evaluator	Polymer ID Polyethylene Polymer ID Polypropylene System Suitability Parameters Checker Polymer ID EVA	Package Integrity & Leak Test Quality Checker FTIR Identity Quality Checker Elemental Impurities ICP Quality Checker Particle Count Injection USP <788> Quality Checker	Electrical Safety Test Summary Checker EMCTest Coverage Checker Biocompatibility Gap Assessment Checker Software Safety Class Checker Design Control Compliance Checker
58. Cutera Предполагаемый fit по профилю группы	Базовые проверкиParticulate Contamination Checker Bioburden Checker Extractables Leachables Risk Assessor Sterility Result Evaluator	Polymer ID Polyethylene Polymer ID Polypropylene System Suitability Parameters Checker Polymer ID EVA	Package Integrity & Leak Test Quality Checker FTIR Identity Quality Checker Elemental Impurities ICP Quality Checker Particle Count Injection USP <788> Quality Checker	Electrical Safety Test Summary Checker EMCTest Coverage Checker Biocompatibility Gap Assessment Checker Software Safety Class Checker Design Control Compliance Checker
59. Solta Medical Предполагаемый fit по профилю группы	Базовые проверкиParticulate Contamination Checker Bioburden Checker Extractables Leachables Risk Assessor Sterility Result Evaluator	Polymer ID Polyethylene Polymer ID Polypropylene System Suitability Parameters Checker Polymer ID EVA	Package Integrity & Leak Test Quality Checker FTIR Identity Quality Checker Elemental Impurities ICP Quality Checker Particle Count Injection USP <788> Quality Checker	Electrical Safety Test Summary Checker EMCTest Coverage Checker Biocompatibility Gap Assessment Checker Software Safety Class Checker Design Control Compliance Checker
60. EndyMed Medical Предполагаемый fit по профилю группы	Базовые проверкиParticulate Contamination Checker Bioburden Checker Extractables Leachables Risk Assessor Sterility Result Evaluator	Polymer ID Polyethylene Polymer ID Polypropylene System Suitability Parameters Checker Polymer ID EVA	Package Integrity & Leak Test Quality Checker FTIR Identity Quality Checker Elemental Impurities ICP Quality Checker Particle Count Injection USP <788> Quality Checker	Electrical Safety Test Summary Checker EMCTest Coverage Checker Biocompatibility Gap Assessment Checker Software Safety Class Checker Design Control Compliance Checker
61. Jeisys Medical Предполагаемый fit по профилю группы	Базовые проверкиParticulate Contamination Checker Bioburden Checker Extractables Leachables Risk Assessor Sterility Result Evaluator	Polymer ID Polyethylene Polymer ID Polypropylene System Suitability Parameters Checker Polymer ID EVA	Package Integrity & Leak Test Quality Checker FTIR Identity Quality Checker Elemental Impurities ICP Quality Checker Particle Count Injection USP <788> Quality Checker	Electrical Safety Test Summary Checker EMCTest Coverage Checker Biocompatibility Gap Assessment Checker Software Safety Class Checker Design Control Compliance Checker
62. Lutronic Предполагаемый fit по профилю группы	Базовые проверкиParticulate Contamination Checker Bioburden Checker Extractables Leachables Risk Assessor Sterility Result Evaluator	Polymer ID Polyethylene Polymer ID Polypropylene System Suitability Parameters Checker Polymer ID EVA	Package Integrity & Leak Test Quality Checker FTIR Identity Quality Checker Elemental Impurities ICP Quality Checker Particle Count Injection USP <788> Quality Checker	Electrical Safety Test Summary Checker EMCTest Coverage Checker Biocompatibility Gap Assessment Checker Software Safety Class Checker Design Control Compliance Checker
63. Apyx Medical Предполагаемый fit по профилю группы	Базовые проверкиParticulate Contamination Checker Bioburden Checker Extractables Leachables Risk Assessor Sterility Result Evaluator	Polymer ID Polyethylene Polymer ID Polypropylene System Suitability Parameters Checker Polymer ID EVA	Package Integrity & Leak Test Quality Checker FTIR Identity Quality Checker Elemental Impurities ICP Quality Checker Particle Count Injection USP <788> Quality Checker	Electrical Safety Test Summary Checker EMCTest Coverage Checker Biocompatibility Gap Assessment Checker Software Safety Class Checker Design Control Compliance Checker
64. Ellman International Предполагаемый fit по профилю группы	Базовые проверкиParticulate Contamination Checker Bioburden Checker Extractables Leachables Risk Assessor Sterility Result Evaluator	Polymer ID Polyethylene Polymer ID Polypropylene System Suitability Parameters Checker Polymer ID EVA	Package Integrity & Leak Test Quality Checker FTIR Identity Quality Checker Elemental Impurities ICP Quality Checker Particle Count Injection USP <788> Quality Checker	Electrical Safety Test Summary Checker EMCTest Coverage Checker Biocompatibility Gap Assessment Checker Software Safety Class Checker Design Control Compliance Checker
65. Zimmer MedizinSysteme Предполагаемый fit по профилю группы	Базовые проверкиParticulate Contamination Checker Bioburden Checker Extractables Leachables Risk Assessor Sterility Result Evaluator	Polymer ID Polyethylene Polymer ID Polypropylene System Suitability Parameters Checker Polymer ID EVA	Package Integrity & Leak Test Quality Checker FTIR Identity Quality Checker Elemental Impurities ICP Quality Checker Particle Count Injection USP <788> Quality Checker	Electrical Safety Test Summary Checker EMCTest Coverage Checker Biocompatibility Gap Assessment Checker Software Safety Class Checker Design Control Compliance Checker
66. INDIBA Предполагаемый fit по профилю группы	Базовые проверкиParticulate Contamination Checker Bioburden Checker Extractables Leachables Risk Assessor Sterility Result Evaluator	Polymer ID Polyethylene Polymer ID Polypropylene System Suitability Parameters Checker Polymer ID EVA	Package Integrity & Leak Test Quality Checker FTIR Identity Quality Checker Elemental Impurities ICP Quality Checker Particle Count Injection USP <788> Quality Checker	Electrical Safety Test Summary Checker EMCTest Coverage Checker Biocompatibility Gap Assessment Checker Software Safety Class Checker Design Control Compliance Checker
67. Capenergy Medical Предполагаемый fit по профилю группы	Базовые проверкиParticulate Contamination Checker Bioburden Checker Extractables Leachables Risk Assessor Sterility Result Evaluator	Polymer ID Polyethylene Polymer ID Polypropylene System Suitability Parameters Checker Polymer ID EVA	Package Integrity & Leak Test Quality Checker FTIR Identity Quality Checker Elemental Impurities ICP Quality Checker Particle Count Injection USP <788> Quality Checker	Electrical Safety Test Summary Checker EMCTest Coverage Checker Biocompatibility Gap Assessment Checker Software Safety Class Checker Design Control Compliance Checker
68. Soring Предполагаемый fit по профилю группы	Базовые проверкиParticulate Contamination Checker Bioburden Checker Extractables Leachables Risk Assessor Sterility Result Evaluator	Polymer ID Polyethylene Polymer ID Polypropylene System Suitability Parameters Checker Polymer ID EVA	Package Integrity & Leak Test Quality Checker FTIR Identity Quality Checker Elemental Impurities ICP Quality Checker Particle Count Injection USP <788> Quality Checker	Electrical Safety Test Summary Checker EMCTest Coverage Checker Biocompatibility Gap Assessment Checker Software Safety Class Checker Design Control Compliance Checker
69. BTL Industries Предполагаемый fit по профилю группы	Базовые проверкиParticulate Contamination Checker Bioburden Checker Extractables Leachables Risk Assessor Sterility Result Evaluator	Polymer ID Polyethylene Polymer ID Polypropylene System Suitability Parameters Checker Polymer ID EVA	Package Integrity & Leak Test Quality Checker FTIR Identity Quality Checker Elemental Impurities ICP Quality Checker Particle Count Injection USP <788> Quality Checker	Electrical Safety Test Summary Checker EMCTest Coverage Checker Biocompatibility Gap Assessment Checker Software Safety Class Checker Design Control Compliance Checker
70. DEKA Предполагаемый fit по профилю группы	Базовые проверкиParticulate Contamination Checker Bioburden Checker Extractables Leachables Risk Assessor Sterility Result Evaluator	Polymer ID Polyethylene Polymer ID Polypropylene System Suitability Parameters Checker Polymer ID EVA	Package Integrity & Leak Test Quality Checker FTIR Identity Quality Checker Elemental Impurities ICP Quality Checker Particle Count Injection USP <788> Quality Checker	Electrical Safety Test Summary Checker EMCTest Coverage Checker Biocompatibility Gap Assessment Checker Software Safety Class Checker Design Control Compliance Checker
71. Fotona Предполагаемый fit по профилю группы	Базовые проверкиParticulate Contamination Checker Bioburden Checker Extractables Leachables Risk Assessor Sterility Result Evaluator	Polymer ID Polyethylene Polymer ID Polypropylene System Suitability Parameters Checker Polymer ID EVA	Package Integrity & Leak Test Quality Checker FTIR Identity Quality Checker Elemental Impurities ICP Quality Checker Particle Count Injection USP <788> Quality Checker	Electrical Safety Test Summary Checker EMCTest Coverage Checker Biocompatibility Gap Assessment Checker Software Safety Class Checker Design Control Compliance Checker

Источники списков компаний

Почему выбирают FUZKK Utilities?

✅ Замена Excel

Никаких скрытых формул и случайных правок. Детерминированная логика, версионность и воспроизводимые результаты.

🔍 Готовность к аудиту (IQ/OQ)

Каждая утилита поставляется с шаблонами URS & FS. Это ускоряет подготовку к валидации и инспекциям.

⏱ Экономия времени ОКК

Автоматизация проверок, расчётов и отчётности. Команда фокусируется на отклонениях и научной оценке, а не на форматировании.

🚀 Быстрое внедрение

CSV-вход и JSON-выход позволяют интегрировать пакет без разработки тяжёлых LIMS-модулей с нуля.

Схема интеграции

LIMS / ELN / CSV-export → утилита FUZKK → output.json → QMS / eDMS / batch release

Утилиты читают CSV-вход и формируют структурированный JSON-результат, пригодный для автоматизированного batch release, QA/QC review и интеграции с LIMS/ELN/MES.

Утилиты и проверяемые параметры

№	API / продукт	Утилита	Ключевые проверки
1	particulate-contamination-checker	`particulate contamination checker`	Детерминированная QC-проверка по входному CSV с JSON-результатом для QA/QC review.
2	sterility-result-evaluator	`sterility result evaluator`	Детерминированная QC-проверка по входному CSV с JSON-результатом для QA/QC review.
3	bioburden-checker	`bioburden checker`	Детерминированная QC-проверка по входному CSV с JSON-результатом для QA/QC review.
4	extractables-leachables-risk-assessor	`extractables leachables risk assessor`	Детерминированная QC-проверка по входному CSV с JSON-результатом для QA/QC review.
5	polymer-id-eva	`polymer id eva`	Детерминированная QC-проверка по входному CSV с JSON-результатом для QA/QC review.
6	polymer-id-polyethylene	`polymer id polyethylene`	Детерминированная QC-проверка по входному CSV с JSON-результатом для QA/QC review.
7	polymer-id-polypropylene	`polymer id polypropylene`	Детерминированная QC-проверка по входному CSV с JSON-результатом для QA/QC review.
8	aas-glass-leachables-test	`aas glass leachables test`	Детерминированная QC-проверка по входному CSV с JSON-результатом для QA/QC review.
9	system-suitability-parameters-checker	`system suitability parameters checker`	Детерминированная QC-проверка по входному CSV с JSON-результатом для QA/QC review.
10	package-integrity-leak-test-quality-checker	`package integrity leak test`	Детерминированная QC-проверка по входному CSV с JSON-результатом для QA/QC review.
11	particle-count-injection-usp788-quality-checker	`particle count injection usp788`	Детерминированная QC-проверка по входному CSV с JSON-результатом для QA/QC review.
12	environmental-monitoring-cleanroom-quality-checker	`environmental monitoring cleanroom`	Детерминированная QC-проверка по входному CSV с JSON-результатом для QA/QC review.
13	ftiridentity-quality-checker	`ftiridentity`	Детерминированная QC-проверка по входному CSV с JSON-результатом для QA/QC review.
14	elemental-impurities-icpquality-checker	`elemental impurities icpquality checker`	Детерминированная QC-проверка по входному CSV с JSON-результатом для QA/QC review.
15	design-control-compliance-checker	`design control compliance checker`	Детерминированная QC-проверка по входному CSV с JSON-результатом для QA/QC review.
16	risk-management-report-completeness-checker	`risk management report completeness checker`	Детерминированная QC-проверка по входному CSV с JSON-результатом для QA/QC review.
17	risk-control-traceability-checker	`risk control traceability checker`	Детерминированная QC-проверка по входному CSV с JSON-результатом для QA/QC review.
18	requirement-traceability-checker	`requirement traceability checker`	Детерминированная QC-проверка по входному CSV с JSON-результатом для QA/QC review.
19	process-validation-checker	`process validation checker`	Детерминированная QC-проверка по входному CSV с JSON-результатом для QA/QC review.
20	electrical-safety-test-summary-checker	`electrical safety test summary checker`	Детерминированная QC-проверка по входному CSV с JSON-результатом для QA/QC review.
21	emctest-coverage-checker	`emctest coverage checker`	Детерминированная QC-проверка по входному CSV с JSON-результатом для QA/QC review.
22	biocompatibility-gap-assessment-checker	`biocompatibility gap assessment checker`	Детерминированная QC-проверка по входному CSV с JSON-результатом для QA/QC review.
23	software-safety-class-checker	`software safety class checker`	Детерминированная QC-проверка по входному CSV с JSON-результатом для QA/QC review.

Позиционирование пакета

Пакет является маркетинговой и технической подборкой. Его удобно использовать для первичного разговора с ОКК/QC, оценки покрытия портфеля, пилота и подготовки интеграции.

three-layer four-column company map Product API Lumex LabEx Medical Devices company utility mapping rf medical-devices lifecycle risk management software lifecycle QMS company map radiofrequency-ablation-companies portfolio evidence product-specific utility fit possibly relevant public product portfolio 2026 v3 three FUZKK layers four utility columns Lumex Instrumental layer LabEx Instrumental layer 2026 v3.1

Лицензирование и поддержка

Лицензия предоставляется одной фармацевтической компании или производственной площадке, без права распространения.
Утилиты предоставляются «как есть»; валидацию выполняет клиент с использованием URS & FS / IQ/OQ-шаблонов.
Доступна интеграционная поддержка для LIMS/ELN/MES, подготовки пилота и уточнения CSV/JSON-потока.
Публичная цена не указана: коммерческое предложение зависит от состава пакета, количества площадок, модели поставки и объёма поддержки.

Вопросы? Нужна демонстрация или пилот для ОКК?

Представитель — FUZKK Pharma Utilities

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