We can’t cover all aspects of the ISO standard and 21 CFR Part 820 regulation in this post, so we will focus on five key areas:Ī QMS cannot function without solid document control. Five Broad Topics Covered in the ISO Standard and FDA Regulation We’ve combined all three posts into one easy-to-read white paper, plus added some extras. In this final post we will take a look at key sections of ISO 13485:2016 and the FDA Quality System Regulations. 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. This is blog post 3 of 3 in our series on Medical Device Quality Management Systems.
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