Category: ISO 13485:2016

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

2019 JourneyThe 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 and in vitro diagnostic regulations (EU MDR and EU IVDR, respectively) will certainly demand more attention from regulatory professionals in 2019.…

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All Topics, Complaint Handling and Postmarket Surveillance, EU Medical Device Regulation (MDR 2017/745), ISO 13485:2016, Risk Management/ISO 14971

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.

Paperwork OverloadCongratulations. 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 correctly translated into written production specifications.…

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All Topics, Design Control, ISO 13485:2016, US FDA 21 CFR Part 820 (QSR)

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.

Fixing DevicesEarlier (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 defined and tracked.…

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All Topics, Design Control, ISO 13485:2016, US FDA 21 CFR Part 820 (QSR)

Understanding Medical Device Design Controls: What, Why, and How

This is the first post in a 3-part blog series on medical device design control. In subsequent post we look at design inputs and outputs, and then DHR, DHF and DMRs. We’ve combined all three posts into one easy-to-read PDF, plus added some extras. Download it here.

Men Working on Engineering Project

Coding changes. Materials substitution. Design refinements. UX improvements. Manufacturing changes.

Medical devices, like all products and software, are constantly evolving. Yet, due to the nature of medical devices and their impact on personal health and safety, the entire product life cycle of a device must be carefully documented.…

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All Topics, Design Control, ISO 13485:2016, US FDA 21 CFR Part 820 (QSR)
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