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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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. 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 […]

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Whew. You Successfully Finished Your ISO 13485 Internal or Supplier Audit. Now What?

In our previous blog posts, we talked about how to prepare and plan for your ISO 13485 audit and provided tips on how to conduct the QMS audit. In this final post, we will discuss the preparation of the audit report and your obligations for following up to ensure corrective actions are being addressed. We’ve combined all three posts into one easy-to-read PDF. Download it here   Want to learn more about ISO 13485 auditing? Consider our ISO 13485 Lead Auditor […]

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Day 1 Conducting Your ISO 13485:2016 Audit. How to Ensure it Goes Smoothly.

In our previous post on ISO 13485:2016 auditing, we talked about how to plan your ISO 13485 QMS audit. In this post we will take the next step and provide tips on how to conduct the opening meeting, interact with auditees, and conduct the closing meeting. In our final post, we’ll talk about audit reporting and follow up activities. We’ve combined this entire series into one easy-to-read PDF. Download it here   Want to learn more about ISO 13485 auditing? Consider […]

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