Module 14 2022

22/03/2022

THE BEST WAY TO CONTROL ERRORS IS TO STOP THEM BEFORE THEY OCCUR

• By designing the MEDICAL DEVICE so that the error will not occur in the first place

Masterclass: Lecture 2

The Organisation for Professionals in Regulatory Affairs

35

• The US FDA identifies 4 steps for this: 1. Identify anticipated / unanticipated use-related hazards 2. Describe how hazardous use scenarios occur 3. Develop and apply strategies to control use-related hazards 4. Demonstrate safe and effective device use (simulated use testing) THE BEST WAY TO CONTROL ERRORS IS TO STOP THEM BEFORE THEY OCCUR

Masterclass: Lecture 2

The Organisation for Professionals in Regulatory Affairs

36

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