The FDA QSIT: Understanding What Happens During a Medical Device QMS Inspection

QSIT Audit

Unlike Regulatory Authorities in most other countries, the US Food and Drug Administration (FDA) relies on random inspections to keep medical device manufacturers honest. Random audits can occur at any time, and that means manufacturers must always remain in compliance with the FDA Quality System Regulation (QSR). There are simply too many medical device manufacturers for FDA to inspect annually, so FDA prioritizes its limited inspection staff according to the risk posed by manufacturers and their devices. Some companies get […]

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Listen and Learn: Develop These Soft Skills and Become a Better Medical Device Auditor

You’ve heard it many times before: “Great (insert any profession here) are made, not born.” The saying is especially applicable to auditors. Truly effective auditors seem to have an ability to effortlessly extract nuggets of good information from their interviewees. They know how to use certain techniques to dig deeper even when their subjects are less than forthcoming. While some auditors may find it easier than others to develop these soft skills, they are very learnable skills. Focus on What Is […]

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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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The Medical Device Single Audit Program: How to Prepare for (and Maintain) MDSAP Certification

The Medical Device Single Audit Program (MDSAP) is a cooperative effort between the medical device regulators in the US, Canada, Japan, Australia and Brazil. Argentina, South Korea, and Singapore participate as affiliate members. The challenges of preparing for your first MDSAP audit are substantial, but so are the long-term benefits. One audit allows you to meet the quality requirements of five major regulators. Unfortunately, Europe is not among them. Many people ask whether an MDSAP audit is more similar to […]

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