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21 CFR Part 11: A Complete Guide - Featured Image

21 CFR Part 11: A Complete Guide

By Jon Speer on September 10, 2018
Medical device companies that wish to sell their devices in the US and EU must implement a quality m...
8 Tips to Comply With FDA 21 CFR Part 11 - Featured Image

8 Tips to Comply With FDA 21 CFR Part 11

By Jon Speer on May 22, 2017
When it comes to compliance among medical device companies, there is a lot of misleading information...
An Introduction to FDA 21 CFR Part 11 - Featured Image

An Introduction to FDA 21 CFR Part 11

By Jon Speer on October 25, 2016
Every week that goes by, I talk to several medical device companies all over the world who have esta...

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