FDA - 10-Jan-94, Guideline for the Manufacture of In Vitro Diagnostic Products.
FDA - 11-May-2005, Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.
FDA - 9-Sep-99, Guidance for Industry, FDA Reviewers and Compliance on Off-The-Shelf Software Use in Medical Devices.
FDA - 11-Jan-02, General Principles of Software Validation Final, Guidance for Industry and FDA Staff .
FDA - Blue Book #G95-1, Required Biocompatibility Training and Toxicology Profiles for Evaluation of Medical Devices.
FDA - Code of Federal Regulations (CFR) Title 21 Part 11: 201 Subpart A; 801 Subpart A; 803; 806; 807; 820; 821.
FDA - CPG 7382.845 (7 Feb 2001), Inspection of Medical Device manufacturers-Final Guidance for Industry and FDA.
FDA - Food Drug, and Cosmetic (FD&C) Act, Sections 201, 301-4; 501-2; 510, 513, 518,704.
FDA - QSIT: 8/99, Guide to Inspection of Quality Systems.
GHTF/SG2/N54R8: 2006, Medical Devices Post Market Surveillance: Global Guidance for Adverse Event Reporting for Medical Devices.
GHTF/SG3/N99-10: 2004, Process Validation Guidance.
GHTF/SG4, Guidelines for Regulatory Auditing of Quality Systems of Medical Device Manufacturers General Requirements, Parts 1-5.
GHTF/SG4(00) 3, Training Requirements for Auditors.
Gryna, Frank M., Richard Chua, and Joseph Defeo. Juran's Quality Planning and Analysis for Enterprise Quality. 5th ed. New York: McGraw-Hill Co, 2007.
IEC 80001-1: 2010 Application of risk management for IT-networks incorporating medical devices -- Part 1: Roles, responsibilities and activities.
IEC/TR 80002-1:2009, Medical device software - Part 1: Guidance on the application of ISO 14971 to medical device software.
IEC 60601-1: 2005, Medical electrical equipment - Part 1:General requirements for basic safety and essential performance.
ISO 11135-1: 2007, Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices.
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 11138-1: 2006, Sterilization of health care products - Biological indicators - Part 1: General requirements.
ISO 11737-1: 2006, Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products.
ISO 11607-1: 2006, Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems.
ISO 10993-1: 2009, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process.
ISO 14644-1: 1999, Part 1: Classification of air cleanliness, cleanrooms, and associated controlled environments.
ISO 13485:2003, Medical devices - Quality management systems - Requirements for regulatory purposes.
ISO 17665-1: 2006, Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices.
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: 2007, Medical devices - Application of risk management to medical devices.
ISO 17025: 2005, General requirements for the competence of testing and calibration laboratories.
ISO 14969: 2004, Medical Devices - Quality Management systems - Guidance on the application of ISO 13485:2003
ISO/IEC 62366: 2008 Medical devices - Application of usability engineering to medical devices
Ishikawa, Kaoru. Guide to Quality Control. White Plains, NY: Quality Resources, 1986. ISBN 9283310365
Juran, Joseph M. Juran's Quality Handbook. 6th ed. Milwaukee, WI: ASQ Quality Press, 2010.