Medical Device Test Protocols - Are you in compliance?


By Engaged Expert

Maciej Jakucki

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Maciej Jakucki has performed and managed a wide variety of medical testing projects and programs to meet FDA and CE requirements.

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. 

To learn more about developing medical device test protocols, complete the form below and access our free recorded webinar.

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