A successful IVDR submission depends on well-structured, compliant technical documentation supported by appropriate clinical evidence and quality management processes.
This webinar explores what reviewers expect and best practice guidance on how manufacturers can improve and strengthen documentation to minimize unnecessary delays and questions during their assessment.
Agenda
- Welcome and introduction
- Building IVDR-compliant technical documentation
- Performance evaluation and supporting evidence
- Lessons learned and common pitfalls
- Audience Q&A.
What you will learn
- The key components of IVDR technical documentation;
- Common documentation deficiencies identified during reviews;
- How to align performance evaluation, risk management and post-market planning; and
- How to improve submission readiness through internal review.
Please note: For Class A sterile devices, Notified Body involvement is limited to aspects relating to the establishment, securing and maintenance of sterile conditions.
Speakers
Adrianne Halliday
Technical Team Manager, BSI
Nathalie Beaudoin
Senior Business Development Manager - IVDR Lead, BSI
Questions? Contact us at: us.medicaldevices@bsigroup.com
