FDA – Code of Federal Regulations (CFR) Title 21 Part: 4; 7; 11; 58; 201 Subpart A; 801 Subpart A; 803; 806; 807; 820; 821; 830. Link
FDA – 27-Sep-19, Guidance for Industry, FDA Reviewers and Compliance on Off-The-Shelf Software Use in Medical Devices. Link
FDA – 11-Jan-02, General Principles of Software Validation Final, Guidance for Industry and FDA Staff. Link
FDA – Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices Link
FDA – Guidance Document for Applying Human Factors and Usability Engineering to Medical Devices Link
GHTF/SG3/N99-10: 2004, Quality Management Systems – Process Validation Guidance Link
Health Canada- SOR/98-282 Medical Devices Regulations Link
RoHs – Restriction of the use of certain hazardous materials in electrical and electronic equipment directive 2011/65/EU:EU Directive for Restriction of the use of certain hazardous materials in electrical equipmentLink
IEC 62304: 2006: Medical device software, software life cycle processes.
IEC 62366-1: 2015 Medical devices – Application of usability engineering to medical devices
ISO 13485:2016, Medical devices -- Quality management systems -- Requirements for regulatory purposes
ISO 9001:2015, Quality management systems – Requirements
ISO/IEC 17025: 2017, General requirements for the competence of testing and calibration laboratories.
ISO 11137-1:2006, Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices.
ISO 11607-1: 2006, Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems.
ISO 10993-1: 2018, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process.
ISO 14644-1: 2015, Cleanrooms, and associated controlled environments - Part 1: Classification of air cleanliness by particle concentration
ISO 14644-2: 2015, Cleanrooms, and associated controlled environments - Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration
ISO 14937: 2009, Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
ISO 14971: 2019, Medical devices -Application of risk management to medical devices.
ISO 15223-1: 2016, Medical devices -- Symbols to be used with medical device labels, labelling and information to be supplied -- Part 1: General requirements