Module 14: Design Development and Certification of Medical Devices

17/11/2023

4 common problems to avoid… (according to the US FDA)

1. Ignoring ISO 14971: 2019 ◦

Reduction of risks “as far as possible” and not ALARP ◦ Establish risk control measures for ALL risks and not just for those that are unacceptable. ◦ Perform a risk / benefit analysis for all risks ◦ Risk reduction must go beyond the information provided to the user. 2. Treating risk management and design controls as distinct processes.

Masterclass: Lecture 2

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4 common problems to avoid… (according to the US FDA)

3. USING FMEA AS A RISK MANAGEMENT MODEL FOR MEDICAL DEVICES ◦ This is effective for measuring failure modes and reliability but it doesn’t fully align with ISO 14971. ◦ Use ISO 14971 as the basis of your risk management process

4. Treating risk management as a checklist item ◦ It’s much broader than that!

Masterclass: Lecture 2

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