David Amor
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.
ARTICLES BY DAVID AMOR
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![Amor_series_logo]( "Usability's Importance In Combination Products: The Mylan Citizen Petition Case Study")
Usability's Importance In Combination Products: The Mylan Citizen Petition Case Study10/25/2016Citizen petitions often are submitted to question or persuade FDA to examine product safety issues, but they also have been abused to prevent products from reaching market. Sharp attention to usability and human factors can give you the upper hand, though, if your company is targeted by this underhanded strategy.
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Understanding Medical Device QMS Requirements For Combo Products: Medical Device Company Edition6/27/2016
This article is the second in a two-part series focusing on 21 CFR Part 4 requirements for drug-device combination product manufacturers. This article examines what medical device companies with a QMS compliant to 21 CFR 820 need to comply with from the 21 CFR 210/211 (pharma/ drug) side.
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Understanding Medical Device QMS Requirements For Combo Products: Pharma Company Edition3/14/2016
In the spirit of reducing the QMS burden on companies developing combination products, FDA acknowledged that there is no need for redundant cGMP requirements that are analogous between drug and device regulations. That said, drug companies should understand the implications of the required 21 CFR 820 subparts, and why they were deemed critical enough to consider for implementation.
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How To Determine A Combination Product's Primary Mode of Action (PMOA)1/22/2016
While principal mode of action may be easy to determine for some combination products, others - particularly those with multiple indications for use - can be much trickier. Here's how to determine the most appropriate PMOA, and corresponding regulatory pathway, for your combination product.
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A Primer On Investigational Drug/Delivery Device Regulatory Requirements11/16/2015
Combination drug/device delivery products are becoming the standard of care in many therapeutic areas, but a cloud of confusion persists surrounding investigational products: What are the requirements for drug/delivery devices used in clinical trials?