Guide to Software Testing for FDA Compliance

Is your medical device software ready for an FDA Audit? Find out with our quick, 9-point checklist. Avoid release delays and make sure your product is up to FDA compliance the first time around.

Download Checklist to Avoid Release Delays and Ensure Your Product Is FDA Compliant

Frequently Asked Questions (FAQs)

Why do I need to fill out the information requested?

We ask for your information in exchange for this valuable resource so that we can share other related information we think will help you with your software testing process. You can read more about our privacy policy here.

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This checklist will:

  • Help You Get to Market Faster

    If you don’t meet FDA compliance requirements the first time, it can delay your release and impact revenue
  • Keep You Organized and on the Right Track

    Outlines everything you need to implement in order to stay FDA compliant
  • Create a Comprehensive Testing Strategy

    Ensure your teams, processes and data are aligned for success from the start
Software Testing of Medical Devices for FDA Audits Process Checklist
Don't forget detailed screenshots, hand writtern print outs, dry runs and for record testing to meet regulatory audits

Why QASource?

They have a solid knowledge of the product as well as how to use current automation tools. Thank you for being an effective liaison and kudos to QASource for working to expand the knowledge needed for our line of work.

Sr. Quality Engineer,
Leading Healthcare & Life Sciences Solutions Provider

Guide to Software Testing for FDA Compliance

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