Requirements
Who is the personal certification as QA/RA for?
Personal certification as QA/RA leader has been developed to ensure that the person being certified has at least the level of experience required Person Responsible for Regulatory Compliance (PRRC) as required in Article 15 in the EU regulations for Medical Devices (MDR 2017/745) and In-Vitro Diagnostics (IVDR 2017/746).
To fulfil the role “person responsible for regulatory compliance” and in addition to this also give proof of knowledge in relevant areas for this role.
Both the experience and the knowledge required is specified in the Requirement document. To maintain certification within the program, the person needs to show objective evidence of continued experience and training to stay current and updated when regulatory requirements change.
Next examination: Proctored online exam at a time planned to suit your needs.