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David Amor

Advisor Greater Minneapolis-St. Paul Area, US

FDA Regulatory and Quality Expert - Medical Devices, Combination Products, mHealth

FDA Regulatory and Quality Expert - Medical Devices, Combination Products, mHealth

4 vouches

Involved In


Urotronic Inc.
UroTech Surgical


Adjunct Professor St. Cloud State University April 2015 - present
Chief Operations Officer; VP of Quality & Regulatory ReMind Technologies LLC June 2013 - present
Managing Partner & Principal Consultant Medgineering™ January 2008 - present
Senior Innovation Fellow, Medical Devices University of Minnesota August 2011 - August 2012
Consultant, Quality Engineer (GCI) Boston Scientific May 2010 - August 2011
Teaching Assistant - FDA Regulations University of Miami Department of Biomedical Engineering January 2011 - May 2011
NIH IMSD and FGAMP Scholar Fellow // Clinical Research/ Commercialization Consultant University of Miami, Miller School of Medicine August 2007 - December 2008


University of Minnesota-Twin Cities Mechanical Engineering 2012 - 2016
University of Miami Biomedical Engineering 2009 - 2010
old school

Interested In

Markets of Interest
  • • Cloud Services
  • • Healthcare
  • • Wearable Tech
  • • Fitness
  • • Quantified-self
  • • Wellness
  • • Medical Devices

You Should Know About Me

Key Accomplishments

• Subject matter expert in combination products (quality and regulatory submissions), design controls, risk management
• Top 40 Under 40 Medical Device Innovators – MDDI 2012, 2013
• Top 35 Under 35 Medtech Professionals – Minnesota Business Magazine
• Adjunct Professor, St. Cloud State University teaching MTQ628 Design Controls/ Risk Management – Regulatory Affairs and Medical
Quality Programs
• Expert in FDA Warning Letter/ 483 Remediation (Design History File, Risk Management, Process Validation, Test Method Validation),
having undergone the same at Boston Scientific, Navilyst Medical, St. Jude Medical, Hospira, amongst others.
• Successful leading of full quality management system (QMS) implementation programs at Top 3 Medical Device Companies, Start-ups
and Contract Development/ Manufacturing Organizations including 21 CFR 820, 21 CFR 210/211 and combination product QMS per 21
CFR 4.
• Successful completion – as lead or supporting Design Quality / Regulatory Consultant – for 510(k), PMA support, TF, Design Dossier,
NDA, ANDA, 505(b)(2)s
• Thought leader in quality and regulatory strategy, evidenced by numerous presentations at world renowned conferences - MD&M West -
Anaheim, MD&M East, MD&M Minneapolis, Software Design for Med Devices, ASQ, MEDDevice San Diego, IQPC Software Quality Conference, ASQ Summit FL and MN. Conference chairman for multiple conferences including Wireless Connectivity in Medical Devic- es, Shenzhen, China, 2014. Regular contributor to Medtech Intelligence, MDDI and MedDevice Online.
• Emeritus, University of Minnesota Medical Device Center, Senior Innovation Fellow 2011
• American Society for Quality, Member, Certified Quality Auditor (CQA)
• GLG Council Member – advisement to private equity and other capital investment groups on medtech/ biotech diligence
• Member, Business Advisory Group (BAG), University of Minnesota Venture Center
• AAMI Combination Product Committee Member (2016)
• AAMI Committee Member - QM/WG 01 – Application of quality systems to medical devices – Primary (2016)
• AAMI Committee Member - QM/WG 04 – Application of risk management to medical devices – Primary (2016)
• Reviewer – Elsevier Advanced Drug Delivery Reviews – regulatory and quality expert (combination products)

How I like to work with people As a Cofounder

Bi-weekly meetings.

As an Advisor

Serve on BOD of only select companies.

Vouches Received

Vouches Given

Think David is awesome?
Vouch for them.

We worked together  •  Managing Partner, Co-Creator of, Medgineering. Previously Account Manager, Partner Sales, SPS Commerce.
A fantastic blend of intelligence and personality with a vision for positively impacting an industry. Also a true subject matter expert.
Roberta Goode
We worked together  •  President, Goode Compliance International. Previously Editorial Advisory Board Member, Medical Device Summit. University of Miami grad.
I have worked directly with David for over 5 years. During this time, I've seen him expertly navigate the changing FDA and OUS regulatory l ... andscape in the life sciences industry with the technical competence of a biomedical engineer and the finesse of a business owner. David's judgment is spot-on, and his grasp of the seemingly contradictory attention to detail and big-picture strategy is disarming. A charismatic leader, David is a rare individual with limitless energy, personal integrity, and a solid grasp of the business of medical device manufacturing.
Christina Vangeloff
We worked together  •  Design Quality Engineer, Physio-Control, Inc.. Previously Quality Engineer, Hospira. University of Miami grad.
David is always customer oriented and is great at scoping work to meet specific needs
Tyler Ebert
We worked together  •  Business Development Partner, ClearPay Financial Solutions LLC.
He honestly knows regulation, quality, and how it fits into a business. He is willing to admit when he is not in his field and defer the dec ... ision. He also has a knack for knowing when to let someone learn something on their own.

Andy Uriarte
They're my school  •  Project Manager, 3D Consultants. Previously Marketing Manager, Adagio Teas. Currently working on software solution in the Healthcare ind.
Andy is a great colleague who has a track record of successful entrepreneurship. all the way from college. His ingenuity has enabled several ... start-up concepts and I look forward to seeing his future launches.