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Need for ISO 13485 certification for PRRC

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Guest user Created:   Dec 09, 2020 Last commented:   Dec 10, 2020

Need for ISO 13485 certification for PRRC

I want to offer my service as PRRC, related to the MDR. Do I need (would it be useful) to have ISO 13485 Certification?

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ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

Expert
Kristina Zvonar Brkić Dec 10, 2020

ISO 13485 is a standard for manufacturing medical devices. So, this is not applicable to you. Your company can be certified according to ISO 9001. However, you need to have proof that you are familiar with ISO 13485. This you can obtain by attending a course for ISO 13485 or become a Lead auditor or internal auditor for ISO 13485.

In MDR, in Article 15 – Person responsible for regulatory compliance is stated which competencies this person need to have a diploma, certificate or other evidence of formal qualification, awarded on completion of a university degree or of a course of study recognized as equivalent by the Member State concerned, in law, medicine, pharmacy, engineering or another relevant scientific discipline, and at least one year of professional experience in regulatory affairs or in quality management systems relating to medical devices.

For a detailed explanation, see:

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Dec 09, 2020

Dec 10, 2020