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7 Tips to Comply With FDA 21 CFR Part 11 - Featured Image

7 Tips to Comply With FDA 21 CFR Part 11

By Jon Speer on January 15, 2020
When it comes to regulatory compliance for medical device companies, there can be some confusion aro...
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...
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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