Our Clients

We enjoy working with all types of companies and partners in the MedTech, Pharma, BioTech, and Digital Health industries.  It provides us with an amazing view of the medical device landscape and a diverse spectrum of technologies that will transform healthcare.   

Over Ten of the Top 50 Global Medical Device & Pharma companies use EdgeOne Medical to augment their device development ecosystem. In addition, we support many of the most innovative early-stage medical technology ventures in the U.S. ,Europe, and Asia as well as Universities, Hospitals, Research Centers, and Professional Investors.  

We respect the confidential nature of the work we do for our clients, and offer the following testimonials regarding our past collaborations.  

Established Firms
Emerging Firms

"The Team at EdgeOne Medical really played a critical role in the development of our Strategic Product Platform by acting as Project Manager and overseeing the development of the prototype. Our firm had never developed a medical device component of a combination product before and needed a trusted and experienced team partner to do it. EdgeOne Medical was able to partner with a world-class Design & Engineering firm that developed an innovative prototype that exceeded our expectations and was on schedule."
Sr. Director of Global Marketing, Confidential Fortune 1000 Pharmaceutical company

"EdgeOne Medical did a great job of delivering high quality work with an aggressive schedule for the testing project."
Sr. Manager, Engineering, Confidential Fortune 500 Pharmaceutical and Medical Device Company

“As an objective, high quality third party supplier of device verification services, EdgeOne Medical (E1M) is a necessary partner for us to complete our combination product FDA filing and submission. E1M is the only company I found who focuses on design and device verification in a laboratory equivalent of GMP without direct interest in manufacturing the product itself. They follow all the controls, documentation, procedures and validation the FDA expects, and are led by an impressive founder who is responsive, thoughtful and knows her stuff. The E1M staff is very capable, flexible to meet our needs, and exemplary for their clear, timely and direct communication across the project life cycle.”
Principle Engineer, Subsidiary of Fortune 500 Pharmaceutical Company

"We sincerely appreciated your practical & grounded approach to the gap assessment!"
Manager of Quality Engineering, Confidential Fortune 1000 BioPharma company

"Quality systems, regulatory strategies, testing protocols are not necessarily unique"

"However, EdgeOne Medical is unique in putting those all together under one roof and having insights into all of those facets of a new company because invariably when you are in the heat of battle doing things like design verification and validation testing and things go wrong you have all the resources on hand under one roof to solve problems real time and keep on schedule"

"For Early-Stage MedTech firms practicing an asset-light or lean strategy, EdgeOne Medical provides a fantastic landing pad for a virtual organization to have a facility and a domicile that is FDA-registered, a place to manage inventory in a controlled manner, and also hold meetings in Chicago"

Avi Roop, Co-founder & Director Miret Surgical

"EdgeOne Medical provides a balance of discipline, maturity, and market experience to an organization like ours that has a high degree of technical skill but a low degree of experience in quality systems and medical regulations"

"What EdgeOne Medical is best at is listening"  

"They have done a great job of understanding what our skills are and what our needs are and have applied those in way that we learn as we go"

"They are not afraid to push us, and they have been very responsive to our needs as we have pushed backed to them as they have learned about our technology" 

"It is a situation where really one plus one equals a lot more than two in the partnership"

Harry Travis, Former President & CEO of etectRx

"EdgeOne Medical has been a great partner for us"

"We were not clear how to get through the quality and development processes necessary to be FDA compliant"

"EdgeOne Medical helped us understand that process and execute a great development program.  They let us do it very cost effectively and very quickly and come up with a product that is developed in the correct fashion that gives a platform to build a business on top of"

"EdgeOne Medical are very good communicators and very helpful. They have done everything in their power to make the process easy for us, to help us understand what we need to do and help us to be effective and successful."

Kim Orumchian, Co-founder & CEO of Turncare