Medical Device Test Protocols - Are you in compliance?
Why are testing protocols necessary? What should a test protocol include? How can Element help you develop test protocols to ease the submission process?
Test protocol development is a key part of any testing program and often defines what testing is performed, why, and how. The protocol outlines the adherence to specifications for regulatory purposes and communicates the test's intent to all involved parties. While the devices may differ, test protocol development processes are very similar. Taylor Combs, Medical Device Test Engineer, discusses how to write test protocol, common protocol shortfalls, and aligning to industry standards.