Need for ISO 13485 certification for PRRC

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:

• EU MDR Article 15 https://advisera.com/13485academy/mdr/person-responsible-for-regulatory-compliance/