CriTech Research, Inc.

Expert medical device software solutions

CriTech Research, Inc. specializes in providing rigorous testing and compliant medical device software development, ensuring the highest quality of medical devices. The company offers a variety of services including software development, verification, intended use validation, remediation, risk management, AI, and cybersecurity. With its 100% first-time approval rate with both FDA and EU, CriTech Research helps clients improve their products and gain regulatory compliance. By leveraging the Critical Software Development Process, the company adheres to applicable regulations such as FDA Part 820 and Part 11. This enables clients to receive clear firmware documentation and validated software packages. CriTech's services benefit medical device manufacturers by improving product reliability, reducing risks, and ensuring regulatory compliance.