Develop your Medical Technology


Six of the top 20 Global Medical Device and Biopharma firms have gained an edge (and a few smiles) utilizing EdgeOne Medical’s device development services and ISO 13485 certified device testing lab.  Emerging Med Tech firms love us too. Fueled by our passion for helping others advance innovative life-enhancing medical technologies, this is how we have fun.

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Quality, Regulatory, Project Management, and Verification & Validation Testing services on demand

EdgeOne Medical’s services are more impactful because we make sure they are working in concert within your organization and with your partners


  • ISO 13485:2003 certified and FDA compliant Product Development Lab & Platform
  • Cross-Functional Product Development Experts working together as an extension of your team
  • Resources & Knowledge-Sharing designed to help you through the Product Development Life Cycle

New Product Development

Our innovative yet pragmatic approach saves time and reduces risk.

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Product Life Cycle Management

Our focused and responsive support of systems and marketed products increases productivity.

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New Product Development

Product Life Cycle Management

Our innovative yet pragmatic approach saves time and reduces risk.

Our focused and responsive support of systems and marketed products increases productivity.

Learn More
Learn More

EdgeOne Medical's Services, Resources, and Facilities support development at any stage in the product life cycle.

“We have a very positive working relationship with EdgeOne Medical (E1M). E1M has a sophisticated quality system infrastructure, in addition to their expertise in design verification/validation, and we are very impressed with the efficiency and the quality of their deliverables. The staff and leadership are very responsive and easy to work with and we look forward to the next phase of this partnership.”

Director, Drug Delivery and Device Development
Fortune 1000 Pharmaceutical 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 lead 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.”

Principal Engineer, Subsidiary of Fortune 500
Pharmaceutical Company

Comprehensive Resources for Medical Product Development and Life Cycle Management

First Steps, Questions & Answers, and Blog Posts at your fingertips

First Steps

Q & A

Blogs

Welcome MATTER

EdgeOne Medical is proud to be one of the Founding Partners of MATTER, the Chicago-based MedTech and Health IT Incubator.

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Combo Product Industry Survey Results

Download the Combination Product Survey Results. Inquiring minds want to know how industry is doing.

Download Report PDF

Attention Startups!

We have offerings specifically tailored to the challenges early stage Medical Device companies are facing.

Read more

Welcome MATTER

Combo Product Industry Survey Results

Attention Startups!

EdgeOne Medical is proud to be one of the Founding Partners of MATTER, the Chicago-based MedTech and Health IT Incubator.

Download the Combination Product Survey Results. Inquiring minds want to know how industry is doing.

We have offerings specifically tailored to the challenges early stage Medical Device companies are facing.

Read more
Download Report PDF
Read more