We often create the Testing Plan during the preparations for the Pre-Submission for our 510(k) clients. This is one of the most important things that we help clients with and often testing plans are based off of predicate devices, or FDA guidance documents.
The testing plan often covers many areas such as biocompatability, Stability, Software Validation, Sterilization and Shelf Life Testing.
We have templates for creating testing plans for FDA submisssions and offer multiple templates within our 510(k) Webinar Series, or as part of an hourly consulting proposal if you wish us to help create your submission or even just help with the testing plan.
Check out our 510(k) Training Course and Webinar Series at-
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Visit us at-
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Contact-
Rob@13485cert.com
