Medical devices are developed with at least one universal primary goal—to help patients. That can involve treatment, diagnosis, prevention, or recovery. As such, it’s vital a device is determined to be safe and effective in accomplishing its task. Regardless of clinical application, the device needs to perform as intended under all potential conditions.

To ensure this, a test plan is developed that is specific and customized to each medical device. The test plan must take into consideration how and where a device will be used, how it will be transported to that location, potential compatibility issues with the surrounding environment, who will use the device, and other important factors. All of this helps steer the test plan design.

Given the varying requirements for medical device testing around the world, representatives from Nelson Labs and Regulatory Compliance Associates (RCA) responded to a number of questions on the topic. In the following Q&A, Audrey Turley, Biosafety Segment Leader, and Thor Rollins, RM (NRCM), VP, Global Market Segment Leader—Medical from Nelson Labs, joined Jordan Elder, RAC, Director of Regulatory Affairs at RCA, to provide the following comprehensive overview.

Sean Fenske: When it comes to medical device development, what is a test plan? What does it entail?

Audrey Turley: Test plans are developed for multiple scientific areas regarding medical devices. Test plans specifically for biocompatibility, or biological safety, should be…