In Vitro Diagnostic Regulation (IVDR) programme
ObjectivesFor those Implementing the EU IVDR in their organisation, involved in writing technical files or upgrading quality systems for the EU IVDR along with Quality Engineers or Regulatory Affairs professionals.
1. Introduction to the In vitro diagnostic regulation
2. Classification & Conformity
3. Risk & General Safety Performance Requirements (GSPR’s)4. Performance Evaluation
5. Post Market Activities.
Benefits of the course:
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 teaching Notified Bodies and Competent Authorities
No training dates available at the moment.