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 […]

Medical Device Design Inputs, Outputs, Verification, and Validation. What Do They All Mean?

This is the second post in a 3-part blog series on medical device design control. We cover the basics of design control in our first post and look at DHR, DHF and DMR in our final post. We’ve also combined all three posts into one easy-to-read PDF, plus added some extras. Download it here. Earlier (in a previous post) we addressed the importance and necessity of design control planning. Now let’s talk about the specific design inputs that need to be […]

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