Module 14: Design Development and Certification of Medical Devices

17/11/2023

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

59

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

• 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)

Masterclass: Lecture 2

60

30