Module 14: Design Development and Certification of Medical Devices

17/11/2023

RISK MANAGEMENT

IF A RISK IS JUDGED TO BE UNACCEPTABLE…?

• IT MUST EITHER BE ELIMINATED…

…0R REDUCED TO ACCEPTABLE LEVELS

Masterclass: Lecture 2

19

RISK MANAGEMENT

◦ Helps to assure safety of the device

◦ Contributes to the consistency of the manufacturing process.

◦ Identification of design problems before distribution eliminates costs associated with recalls.

◦ Offers a measure of protection from product liability damages

Masterclass: Lecture 2

20

10