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
Jeffrey Brady
Technical Specialist & Scheme Manager, BSI
Nathalie Beaudoin
Senior Business Development Manager, BSI
 

Questions? Contact us at: us.medicaldevices@bsigroup.com

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