Module 14: Design Development and Certification of Medical Devices
22/11/2023
Post-launch
• FORMAL CHANGE MANAGEMENT IS ESSENTIAL.. • Part of ISO 13485 / 21CFR 820 requirements • Proposed changes in design must be assessed for their impact on: • Quality • Safety • Performance • The decisions must be DOCUMENTED • .. and changes implemented via your DESIGN PLANNING process.
Masterclass: Lecture 12
The Organisation for Professionals in Regulatory Affairs
5
Selling and supplying your device
… WHAT DIFFERENTIATES YOUR PRODUCT?
1. CLINICAL DATA 2. DESIGN OPTIMISATION
Masterclass: Lecture 12
The Organisation for Professionals in Regulatory Affairs
6
3
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