Module 14: Design Development and Certification of Medical Devices

22/11/2023

Technical Documentation – Questions Raised

These are early trends and may change with time and more experience

The Organisation for Professionals in Regulatory Affairs

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Technical Documentation – General Feedback

 All relevant reports must be provided  Avoid “chain referencing”  Know your audience – provide context and evidence  Review file fully before submitting  Legacy device challenges  Stand-alone new application file required  Clear organization of files and data  Large numbers of reports with no explanation will slow review time

The Organisation for Professionals in Regulatory Affairs

12

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