Experts in Medical Device Software
CriTech Research develops and tests safety-critical software used for medical devices. CriTech is ISO 13485 certified and has provided software engineering services exclusively to the medical device industry since 1994.
We provide custom solutions to meet your specific software engineering needs. We offer a variety of services, including Software Development, Software Verification and Validation, Software Remediation, Software Safety/Risk Engineering, and Due Diligence. CriTech’s staff has diverse backgrounds in microcontroller, PC-based systems, web-based systems, mobile medical applications, and Software as a Medical Device (SaMD). We have specialized expertise in communications and GUI development. In addition, we have experience in designing databases to support both dedicated applications and cloud-based servers.
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).
Our expert software engineers and quality staff are ready to assist in getting your medical device software compliant. We can start any time during your life cycle process – the sooner, the better as early error detection reduces risk significantly!