Quality Training

Person Responsible for Regulatory Compliance (PRRC)

Objectives

Are you implementing the requirements of the EU
Are you involved in Involved in ensuring a Quality Management System meets the requirements of the EU Medical Device

Content includes

Module Topics:

1. Introduction.
2. A clause by clause by clause look at the responsibilities.
3. The MDCG guidance (mdcg_2019_7 Guidance on Article 15 MDR-IVDR person responsible for regulatory compliance).
4. Demonstrating that responsibilities have been discharged.
5. Delegation of Authority.
6. Economic operator interaction.
7. Small businesses & Subcontracting.
8. Authorized representative rules.

Benefits include:

Practical exercises to incite discussion and Practical exercises to incite discussion and accelerate learning.
Provides an open forum to air concerns and ask questions.
Offers the opportunity to compare notes with industry peers.
A full set of course notes and guidance documents for post-course referral.
Tutors with experience of teaching notifed bodies and competent authorities.

Who should attend

Quality Engineers or Regulatory Affairs Professionals

Upcoming dates:

No training dates available at the moment.