CRITECH

CriTech is headquartered in Saline, Michigan, just south of Ann Arbor. We also have an office in Escazu, Costa Rica, located just west of San Jose. Both offices incorporate an excellent development environment, labs, and conference facilities aimed at enabling high efficiency from our software engineers... Our understanding of the needs of the medical device industry has resulted in FDA approval and the European Union CE Mark for hundreds of devices. We have achieved a 100% first-time approval for our submissions with both the FDA and EU. Our quality system, including our Critical Software Development Process, conforms to applicable FDA Part 820 and Part 11 regulations and IEEE, IEC, ISO, GAMP, and AAMI standards. Our 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 Research helps to ensure your medical device uses rigorously tested, fully compliant..

Also known as: CriTech Research, CriTech Research, Inc.

Primary location: Saline United States