Building The Foundation – Structuring Technical Documentation is Key

This webinar explores what reviewers expect & best practice guidance on how manufacturers can improve & strengthen documentation.

Gain a clear view of the key components of IVDR technical documentation

Learn what reviewers expect and how stronger documentation can help reduce unnecessary questions and delays during assessment.

Speakers

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Technical Team Manager, BSI - AM Session

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Technical Specialist & Scheme Manager, BSI - AM Session

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BDM - IVD, UK and Ireland, BSI - AM Session

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Technical Team Manager, BSI - PM Session

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Senior BDM - IVDR Lead, BSI - PM Session

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BDM, APAC China, BSI - AM Session

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Senior BDM, APAC Korea, BSI - AM Session

Connect directly with our experts and build your understanding of key regulatory requirements and the conformity journey.

Engaging a Notified Body under the In Vitro Diagnostic Medical Devices Regulation (IVDR) for the first time raises a lot of questions. This session explains the conformity assessment process step by step and the role of the Notified Body in your IVDR conformity assessment, giving you a greater understanding of where to start with your IVDR certification journey.

8 October 2026 - 09:00 BST or 16:00 BST

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Understand your ongoing obligations after IVDR certification: post-market surveillance, performance follow-up, and managing the changes that require Notified Body involvement.

10 November 2026 - 09:00 GMT or 16:00 GMT

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Why Join This Series

Talk with our regulatory specialists and dedicated technical experts, who bring deep scientific knowledge of the industry.

An open fireside discussion and live Q&A in every session. Submit your questions when you register.

Understand regulatory requirements and the deficiencies most often raised during assessment, before they cost you time.

Certification is just the beginning. Prepare for ongoing compliance across the full product lifecycle.

Who Should Attend

Regulatory Affairs Managers And Specialists.

Regulatory Affairs Directors.

Quality And Regulatory Professionals.

SME Leadership, Including Managing Directors.