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