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.
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.