Title: Design Change
Course: PW-Course-Import-Test > Section: Module 2: Design Controls

Module 2

As explained in the the Design Control Guidance and depicted in the Mapping the Medical Device Development Process visualizations, Design Change requirements exist to ensure specific Design Control requirements are satisfied. Controlling Design Changes are critical to maintaining product safety, efficacy and intended performance.

Read

In order to gain a greater understanding of the importance of Design Change requirements, read section I (Design Changes) of the Design Control Guidance

Consider the consequences of uncontrolled Design Changes and the potential impact on product performance and safety, as well as regulatory compliance.

In order to practice what you have learned in this module, complete the Design Control Quiz on the next page.