CriTech Research, Inc.

CriTech helps medical device manufacturers ensure their software is fully compliant with major medical device standards. We work exclusively for the medical device industry and have been in business for over 30 years. CriTech specializes in Medical Device Software Development, Testing, Remediation, Risk Management, Artificial Intelligence (AI) & Machine Learning (ML), and Cybersecurity. • ISO 13485:2016 Certification • Focus exclusively on medical device software • 100% first-time approval rate for our work products used in submissions with both the FDA and EU • Offer free project analysis • Solutions for all FDA device classes and IEC 62304 software safety classifications • Flexible, custom-tailored solutions set to meet your specific needs for safety-critical software • Specialized expertise in communications and User Interface (UI) development • Experience in designing databases to support both dedicated applications and cloud-based servers • Consulting for medtech firms to include due diligence, software documentation, and other services Our staff has diverse backgrounds in microcontrollers, PC- based systems, web-based systems, mobile medical applications, and Software as a Medical Device (SaMD). CriTech has been improving product quality and patient safety, one medical device at a time, for over 30 years.