FDA | EU | ISO 13485 | IEEE


ISO 13485

CriTech Research has been ISO 13485 certified since 2012. We are audited every six months to ensure continuing compliance with these international standards.

U.S. Food & Drug Administration (FDA)

CriTech’s IEEE-based Critical Software Development Process 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 ISO 13485:2016 certification and Critical Software Development Process ensures 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.

Regulations and Standards Compliance

CriTech Research has over thirty years of experience developing software and performing independent software verification and validation for regulated industries. 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. 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).

FDA & European Union Regulatory Compliance

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
  • IEC 81001-5-1 Health software and health IT systems safety, effectiveness and security – Part 5-1: Security - Activities in the product lifecycle
  • ISO 13485:2016, Medical Devices — Quality Management Systems — Requirements for Regulatory Purposes
  • ISO 14971:2019 – Medical Devices — Application of Risk Management to Medical Devices
  • FDA's General Principles of Software Validation (GPSV)
  • Good Automated Manufacturing Practice (GAMP)

Software Development Standards

An IEEE-based Critical Software Development Process is a fundamental part of CriTech's quality system. Our process incorporates ISO/IEC 12207 (Systems and Software Engineering — Software Life Cycle Processes), IEC 62304:2006/AMD1:2015 (Medical Device Software — Software Life Cycle Processes), and the International Society of Pharmaceutical Engineering (ISPE) Good Automated Manufacturing Practice (GAMP).