Module 14: Design Development and Certification of Medical Devices

22/11/2023

Same principles – using the “waterfall” diagram approach

Masterclass: Lecture 12

The Organisation for Professionals in Regulatory Affairs

15

Software DESIGN CHANGES

• What are the types of activities which drive it? ● NEW DEMANDS FROM THE PATIENT / HCPs – Demand for increased functionality ● EMERGING NEW PLATFORMS – New technology available that supports optimisation – “old” technology no longer supported ● BUGS, LOOPHOLES THAT REQUIRE FIXING – Unforeseen issues with the software ● MISUSE / ABUSE of the software ● CONCERNS ABOUT CYBER SECURITY – Tighter requirements for data encryption – More legislation on data privacy.

Masterclass: Lecture 12

The Organisation for Professionals in Regulatory Affairs

16

8