FDA & European Union Regulatory Compliance
At CriTech, we follow an IEEE-based critical software development process (CSP), which is a fundamental part of our quality system. Our quality system is compliant with the FDA Quality System Regulation, which supports 510(k) and PMA submissions, and satisfies the software-related requirements of major medical device standards, including:
- EU Medical Device Directive (93/42/EEC)
- IEC 62304:2006/AMD1:2015, Medical Device Software -- Software Life Cycle Processes
- ISO 13485:2016, Medical Devices — Quality Management Systems — Requirements for Regulatory Purposes
- ISO 14971:2007, Medical Devices — Risk Management
- FDA's General Principles of Software Validation (GPSV)
- Good Automated Manufacturing Practice (GAMP)
U.S. Food & Drug Administration (FDA)
CriTech’s IEEE-based Critical Software Development Process (CSP) is designed to develop and test software that meets the requirements of FDA CFR Part 820 (Quality System Regulation) and the FDA General Principles of Software Validation (GPSV). Our work has a 100% first-time acceptance rate from FDA.
European Union (CE Mark)
CriTech’s CSP and ISO 13485 certification ensure that our work will fulfill the essential requirements of the EU Medical Device Directive and help devices attain the CE Mark. Our quality system fully incorporates IEC 62304, the international standard for software life cycle processes. In addition, our software safety analysis process complies with the requirements of the ISO 14971 standard for software risk management.