CriTech Research

CriTech Research Inc., headquartered in Saline, Michigan (near ENDRA's headquarters in Ann Arbor), has more than 20 years of experience in the development and testing of safety-critical software for medical devices. CriTech is certified to ISO13485 and ISO 9001 for software development. CriTech's customers range from large, established companies to startups, with products from all FDA device classes (I, II, III) and IEC 62304 software safety classifications (A, B, C). CriTech's proven history of success with medical device software validation & verification extends to over 400 projects completed and having received FDA and/or EU approval.