CriTech Research helps medical device manufacturers ensure their software is fully compliant with major medical device standards. CriTech Research specializes in Medical Device Software Development, Testing, Remediation, 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.