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
Ana
Chiva
Technical Team Manager, BSI - AM Session
Hedele
Pitman
Technical Specialist & Scheme Manager, BSI - AM Session
Conor
Lavery
Business Development Manager - (In Vitro Diagnostic Devices) UK and Ireland, BSI - AM Session
Adrianne
Halliday
Technical Team Manager, BSI - PM 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
