Achieving certification is only the beginning. Maintaining compliance under IVDR requires ongoing vigilance, robust post-market activities and effective change management.
This webinar focuses on establishing sustainable regulatory processes that support continued compliance throughout the product lifecycle.
Agenda
- Welcome and introduction
- Life after certification: ongoing IVDR responsibilities
- Managing changes and maintaining compliance
- Preparing for surveillance and future assessments
- Audience Q&A and series wrap-up
What you will learn
- Your ongoing obligations following IVDR certification;
- How to plan post-market surveillance and performance follow-up;
- How to manage changes that may require Notified Body involvement; and
- How to build long-term regulatory resilience.
Speakers
Alastair
Collyer
Regulatory Lead Notified Body IVDR, BSI
James
Kerr
Technical Team Manager, BSI - AM Session
Jeffrey
Brady
Technical Specialist & Scheme Manager, BSI - PM Session
Sofia
Morandi
Business Development Manager – IVD - AM Session
Nathalie
Beaudoin
Senior Business Development Manager - IVDR Lead, BSI - PM Session
Riley
Li
Business Development Manager, APAC China, BSI - AM Session
Hyunjung
Koo
Senior Business Development Manager, APAC Korea, BSI - AM Session
