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Data collection and management designed for MedTech clinical trials.

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Posts by Michael Galliker

Get the latest updates and best practices in the MedTech industry from our blog. Join 200,000+ other MedTech professionals outperforming their peers.
Establishing a QMS
Etienne Nichols
February 2, 2024

FDA Publishes Final Rule on QMSR

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Establishing a QMS

Guide to Managing Your Medical Device on the Market and Scaling Manufacturing

Laura Maher
January 3, 2024
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Ultimate Guide to ISO 14155:2020 for Medical Devices

Jon Bergsteinsson
September 15, 2023
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About the Author

Regulatory Affairs Expert in the medical device field. Founder and CEO of Regulatory Globe, a consulting company that offers regulatory tools and resources to medical device companies, specifically in the areas of Medical Device Regulation / EU MDR, In Vitro Diagnostic / IVDR, ISO 13485: 2016 and MDSAP.

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Establishing a QMS

EU MDR Implementation Guide

Michael Galliker
November 5, 2019
The European medical device industry will undergo significant changes as a result of the new medical device regulation which has signed on May 26th, 2017. As the name... Read More

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