EdgeOne Medical Inc.

455, N. Campbell Ave. #2N , 60612 Chicago
USA

Telephone +1 312 3006640-006646
Fax +1 312 277-6483
info@edgeonemedical.com

This company is co-exhibitor of
Messe Düsseldorf North America

Trade fair hall

  • Hall 16 / E10-8
 Interactive Plan

Hall map

MEDICA 2016 hall map (Hall 16): stand E10-8

Fairground map

MEDICA 2016 fairground map: Hall 16

Our range of products

Product categories

  • 07  Medical Services and Publications
  • 07.10  Technical equipment management, Test houses / Certification Bodies

Technical equipment management, Test houses / Certification Bodies

Our products

Product category: Technical equipment management, Test houses / Certification Bodies

V & V Testing

The smart way to extend your limited resources

While there are many testing labs that can generate data, we are an ISO 13485 certified and FDA compliant Medical Device Testing Lab that is led by product development professionals and is supported by in-house quality and regulatory team members. Since we understand the entire device development process and what documentation belongs in a DHF as well as the submission filing, we know the critical difference between "generating data" versus "generating the right data".

More than just a Testing Lab.

So What Makes Us Different?

An Extension of Your Team
Whether you are a large or small company, we engage based on your company's unique realities, goals and priorities, not ours.

ISO 13485 Certified FDA Compliant Lab
Whether conducting an exploratory experiment or design validation, we understand the importance of operating our lab according to global requirements.

Holistic Testing Approach
Knowing how important the V&V data is to the success of your device development program, we challenge the study design and your plan if testing doesn't go as expected.

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About us

Company details

EdgeOne Medical is a Medical Device and Combination Product (Device & a Drug/Biologic) Product Development Consultancy and Testing House based in Chicago, IL that serves large and small Medical Product companies in Europe and the USA.  EdgeOne Medical provides an integrated set of product development capabilities including Regulatory Strategy & Submission,  Quality Systems & Quality Representatives, Project Management, Product Performance Testing for Devices, and Engineering Support.

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Company data

Sales volume

1-9 Mio US $

Export content

max. 50%

Number of employees

1-19

Foundation

2012

Area of business

Medical Services and Publications