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We are a Veteran-Owned Firm.

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About Us

CriTech Research develops and tests safety-critical software and systems for medical device applications. We have over 24 years of experience creating custom solutions, tailored to meet your specific needs. 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. 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). With offices in Saline, Michigan, and Escazu, Costa Rica, we have the talent and capacity to tackle any project.

 

Differentiators Value Proposition Technical Expertise
Portfolio
Compliance Our Process Employment


Robert Rajewski

Robert Rajewski is Co-Founder and President of CriTech Research and is a recognized industry expert in the field of medical device software engineering. He has been involved in the medical device business for over 24 years and has served as an instructor for AAMI/FDA courses on software regulations and software verification and validation.

Robert Rajewski

Facility

Facilities & Resources

Our two facilities include more than 18,000 sq. ft. of modern office space and excellent laboratories with plenty of room to support multiple large projects. We have over 40 engineers on staff.

Compliance

One of the best reasons to use CriTech is for our extensive knowledge of FDA and European Union software development regulations and standards. Our work is performed in compliance with applicable software regulations and standards laid by:

FDA | IEEE | IEC | ISO | GAMP


We specialize in software verification and validation for medical devices.