prosystem-ag.com

PROSYSTEM AG

49 40 668 788-100. EWR (EU and EFTA). Rest of the world. 21 CFR 820 QSR. Inspections by the FDA. Special requirements for medical devices. Documentation of Clinical Evaluation. IVD in the USA. Usability Risk Management Clinical Evaluation. Project management for medical devices. Interim and crisis management. Development according to IEC 62304/IEC 82304. Medical Apps / Health Software. New requirements for your processes and medical devices. Get in touch with solutions. And approval of your application.

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PROSYSTEM AG | prosystem-ag.com Reviews

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49 40 668 788-100. EWR (EU and EFTA). Rest of the world. 21 CFR 820 QSR. Inspections by the FDA. Special requirements for medical devices. Documentation of Clinical Evaluation. IVD in the USA. Usability Risk Management Clinical Evaluation. Project management for medical devices. Interim and crisis management. Development according to IEC 62304/IEC 82304. Medical Apps / Health Software. New requirements for your processes and medical devices. Get in touch with solutions. And approval of your application.

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1 hamburg germany

2 services

3 regulatory affairs

4 quality management

5 risk management

6 clinical evaluation

7 clinical investigation

8 in vitro diagnostics

9 usability

10 project management

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PROSYSTEM AG | prosystem-ag.com Reviews

https://prosystem-ag.com

49 40 668 788-100. EWR (EU and EFTA). Rest of the world. 21 CFR 820 QSR. Inspections by the FDA. Special requirements for medical devices. Documentation of Clinical Evaluation. IVD in the USA. Usability Risk Management Clinical Evaluation. Project management for medical devices. Interim and crisis management. Development according to IEC 62304/IEC 82304. Medical Apps / Health Software. New requirements for your processes and medical devices. Get in touch with solutions. And approval of your application.

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prosystem-ag.com

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PROSYSTEM AG – Risikomanagement › ISO 14971

http://www.prosystem-ag.com/en/risikomanagement-iso-14971

49 40 668 788-100. EWR (EU and EFTA). Rest of the world. 21 CFR 820 QSR. Inspections by the FDA. Special requirements for medical devices. Documentation of Clinical Evaluation. IVD in the USA. Usability Risk Management Clinical Evaluation. Project management for medical devices. Interim and crisis management. Development according to IEC 62304/IEC 82304. Medical Apps / Health Software. Standards & Trends. New requirements for your processes and medical devices. As an active member of the international st...

2

PROSYSTEM AG – Regulatory Affairs › USA

http://www.prosystem-ag.com/en/regulatory-affairs-2/regulatory-affairs-usa

49 40 668 788-100. EWR (EU and EFTA). Rest of the world. 21 CFR 820 QSR. Inspections by the FDA. Special requirements for medical devices. Documentation of Clinical Evaluation. IVD in the USA. Usability Risk Management Clinical Evaluation. Project management for medical devices. Interim and crisis management. Development according to IEC 62304/IEC 82304. Medical Apps / Health Software. Standards & Trends. New requirements for your processes and medical devices. 513(g) Classification of medical devices.

3

PROSYSTEM AG – Risk Management › Special requirements

http://www.prosystem-ag.com/en/risk-management-according-to-iso-14971/risk-management-special-requirements

49 40 668 788-100. EWR (EU and EFTA). Rest of the world. 21 CFR 820 QSR. Inspections by the FDA. Special requirements for medical devices. Documentation of Clinical Evaluation. IVD in the USA. Usability Risk Management Clinical Evaluation. Project management for medical devices. Interim and crisis management. Development according to IEC 62304/IEC 82304. Medical Apps / Health Software. Standards & Trends. New requirements for your processes and medical devices. Risk Management Special requirements.

4

PROSYSTEM AG – Quality Management › ISO 13485

http://www.prosystem-ag.com/en/quality-management-system-for-medical-device-manufacturers/quality-management-iso-13485

49 40 668 788-100. EWR (EU and EFTA). Rest of the world. 21 CFR 820 QSR. Inspections by the FDA. Special requirements for medical devices. Documentation of Clinical Evaluation. IVD in the USA. Usability Risk Management Clinical Evaluation. Project management for medical devices. Interim and crisis management. Development according to IEC 62304/IEC 82304. Medical Apps / Health Software. Standards & Trends. New requirements for your processes and medical devices. Quality Management ISO 13485.

5

PROSYSTEM AG – Clinical Evaluation › Documentation

http://www.prosystem-ag.com/en/clinical-evaluation/clinical-evaluation-documentation

49 40 668 788-100. EWR (EU and EFTA). Rest of the world. 21 CFR 820 QSR. Inspections by the FDA. Special requirements for medical devices. Documentation of Clinical Evaluation. IVD in the USA. Usability Risk Management Clinical Evaluation. Project management for medical devices. Interim and crisis management. Development according to IEC 62304/IEC 82304. Medical Apps / Health Software. Standards & Trends. New requirements for your processes and medical devices. Which marketing claims may be used?

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