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Posts by David Amor

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

David Amor, MSBE, CQA is a medtech/biotech consultant and mobile health entrepreneur who founded Medgineering, a company focused on remote compliance, regulatory, and quality systems consulting for larger companies and start-ups. A graduate of the prestigious Innovation Fellows program at the University of Minnesota’s Medical Device Center, Amor was named a Top 40 Under 40 Medical Device Innovator in 2012 and a 35 Under 35 Entrepreneur in 2015 by Minnesota Business magazine. He co-founded and helped launch Remind Technologies, a Texas-based mobile health company developing a smartphone-based remote medication management system. He is also co-inventor on several issued utility patents and co-pioneered a disruptive e-consulting platform for the medtech and pharma industries called QuickConsult. Amor serves as an adjunct professor at St. Cloud State University (Maple Grove, MN) where he teaches courses on risk management and design control. The current focal points of his consulting practice are specializing in risk management, design controls, combination products, and mHealth.

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Establishing a QMS

How to Evaluate a Company’s Regulatory and Quality ‘Health’ Before Investing

David Amor
August 18, 2019
When asked whether he hires consultants to help him make investment decisions in the MedTech space, an angel investor friend of mine once told me, “spending $5,000–$10,000 on... Read More
Establishing a QMS

EN ISO 14971:2012 Risk Assessment Explained in 5 Minutes… Using the Grossest Example Ever?

David Amor
March 27, 2017
This post was originally published by David Amor on LinkedIn and reposted here with the author's permission. Additional commentary has been added by Jon Speer, where noted. ... Read More
Establishing a QMS

What Medtech Startups Should Know About Quality Systems To Not Go Overboard

David Amor
June 16, 2016
MedTech startups thrive on lean-ness. Part of lean-ness is knowing how and when to scale regulatory and quality requirements for your business while maintaining practical... Read More

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