Non-Product Software Risk Assessment for Medical Device Manufacturers

Here’s a relationship tip. If one day your spouse or partner asks you what you did today, never reply by saying that you were working on a master validation plan for non-product software (NPS). Tell them you were working on a program designed to improve the safety of medical devices. Trust me on this. That tip aside, someday soon you WILL actually be working on this issue and you’re probably here now because – like thousands of other quality and […]

Writing Medical Device Audit Reports That People Will Read – and Take Action On

Whether you are auditing a critical supplier for compliance with 21 CFR Part 820 or conducting an internal MDSAP audit for another facility within your company, the audit report is the most important output of your hard work. The audit report represents the who, what, why, and how of the audit…and your primary goal is to get people to take action. How you go about crafting that report will make a big difference in what action is taken on your […]

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All Topics, Auditing, ISO 13485:2016

6 Medical Device Compliance Issues That Will Demand More of Your Bandwidth in the Next 12 Months

The next 12 months are sure to be a wild ride for medical device RA/QA professionals. There’s a lot going on in the world of regulatory compliance and there is little doubt that your workload is about to increase – you may have seen it happening already. Here’s what we are hearing from our clients about issues they expect will consume more of their precious time this year. 1 – Internal audits and gap assessments The new European medical device […]

What’s the Difference Between a Design History File (DHF), Device Master Record (DMR), and Device History Record (DHR)?

This is the last in a 3-part blog series on medical device design control. In the first post we talked about the basics followed by design inputs and outputs. We’ve also combined all three posts into one easy-to-read PDF, plus added some extras. Download it here. Congratulations. You’ve created all of your design inputs, defined the outputs, and conducted design verification. Your design is complete and you are ready for production. Now it’s time to make sure those design outputs are […]

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