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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Here’s How To Prepare For An ISO 13485 Audit

Congratulations! You have been chosen (or perhaps conscripted) to conduct or participate in an ISO 13485 internal quality management system (QMS) audit. For many, the prospect of coordinating and conducting an audit can be terrifying. However, believe us when we say the terror subsides with each hour of planning you do. In this white paper we will talk about how you can lay the foundation to ensure that your ISO 13485 audit progresses smoothly, yielding input that’s useful to your company’s […]

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Understanding Your Most Important Obligations in ISO 13485:2016 and the US FDA QSR

This is blog post 3 of 3 in our series on Medical Device Quality Management Systems. In our previous blog posts, we provided a high-level overview of medical device quality management systems, followed by a discussion on key components of a QMS that meets US FDA and EU requirements. In this final post we will take a look at key sections of ISO 13485:2016 and the FDA Quality System Regulations. We’ve combined all three posts into one easy-to-read white paper, plus added some extras. […]

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