CriTech Research, Inc. Employee Directory

Software DevelopmentMichigan, United States11-50 Employees

CriTech Research, Inc. operates in the software development space with a focused emphasis on medical device software. The company aims to help medical device manufacturers ensure compliance with major medical device standards, offering services that span development, testing, remediation, risk management, cybersecurity, and AI/ML support within safety-critical contexts. Its approach centers on delivering solutions that align with regulatory requirements across FDA device classifications and IEC 62304, with a stated track record of first-time approval for work products used in submissions with both the FDA and the EU.

Based in East Saline, Michigan, CriTech has a long-standing presence in the medical device sector and positions itself as a specialist partner for medtech firms, providing consulting that covers software documentation, due diligence, and related services. The firm highlights ISO 13485:2016 certification and a tailored service model designed to address the unique needs of safety-critical medical software, including expertise in communications and user interface development and in designing supporting databases. Recent developments include partnerships with Parasoft UK Ltd. and The Realtime Group, reflecting expands in strategic collaborations within the industry.

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