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
Are you Quality Engineers or Regulatory Affairs Professionals
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.
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 notified bodies and competent authorities.