U.S. Food and Drug Administration

• FDA Home Page
• Design Control
  • 21CFR820
  • FDA: Design Control Guidance For Medical Device Manufacturers. 1997-03-11.
  • FDA: Medical Devices; Current Good Manufacturing Practice (CGMP) Final Rule; Quality System Regulation. 1996-10-07.
• Software Development
  • FDA: General Principles of Software Validation; Final Guidance for Industry and FDA Staff. 2002-01-11.
  • FDA: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices. 2005-05-11.
  • FDA: Guidance for Industry, FDA Reviewers and Compliance on Off-The-Shelf Software Use in Medical Devices. 1999-09-09.
  • FDA: Guidance for Industry – Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software. 2005-01-14.
  • FDA: Mobile Medical Applications – Guidance for Industry and Food and Drug Administration Staff. 2013-09-05.
  • FDA: Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices – Guidance for Industry and Food and Drug Administration Staff. 2015-02-09.
  • FDA: Content of Premarket Submissions for Management of Cybersecurity in Medical Devices – Guidance for Industry and Food and Drug Administration Staff. 2014-10-02.
• Interoperability
  • FDA: Design Considerations and Pre- market Submission Recommendations for Interoperable Medical Devices – Guidance for Industry and Food and Drug Administration Staff. 2017-09-06.
• Human Factors
  • FDA: Applying Human Factors and Usability Engineering to Medical Devices Guidance for Industry and Food and Drug Administration Staff. 2016-02-03.
  • FDA: Medical Device Use-Safety: Incorporating Human Factors Engineering into Risk Management. 2000-07-18.
  • Molly Follette Story, PhD, FDA: The FDA Perspective on Human Factors in Medical Device Software Development (Presentation at 2012 IQPC Software Design for Medical Devices Europe). 2012-02-01.
  • Molly Follette Story, PhD, FDA: Human Factors Draft Guidance Document: Agency Expectations for Human Factors Data in Premarket Submissions (Presentation at AAMI/FDA International Conference on Medical Device Standards and Regulation). 2012-03-21.
• Part 11 — Electronic Records, Electronic Signatures
  • 21CFR11
  • Part 11, Electronic Records; Electronic Signatures — Scope and Application
• Other
  • FDA: Radio Frequency Wireless Technology in Medical Devices – Guidance for Industry and Food and Drug Administration Staff. 2013-08-14.
  • FDA: Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications [510(k)] with Different Technological Characteristics – Draft Guidance for Industry and Food and Drug Administration Staff. 2014-07-15.

European Commission

• European standards – Active implantable medical devices
• European standards – In vitro diagnostic medical devices
• European standards – Medical devices

International Standards

• AAMI TIR36:2007 – Validation of Software for Regulated Processes
• AAMI TIR45:2012: Guidance on the use of AGILE practices in the development of medical device software
• ANSI/AAMI HE75, 2009 Edition – Human Factors Engineering — Design of Medical Devices (Link)
• ISO/IEC 12207:2008 – Systems and software engineering — Software life cycle processes
• EN ISO 13485:2012 – Medical devices – Quality management systems – Requirements for regulatory purposes
• EN ISO 14971:2012 – Medical devices – Application of risk management to medical devices
• IEC 62304:2006 Medical device software — Software life cycle processes
• IEC 62366:2007 – Medical devices – Application of usability engineering to medical devices
• IEC TIR 80002-1:2009 – Medical device software – Part 1: Guidance on the application of ISO 14971 to medical device software
• IEC 82304-1:2016 – Health software – Part 1: General requirements for product safety

Health Canada

• Health Canada Home Page
• Medica Devices

Therapeutic Goods Administration (TGA), Australia

• TGA Home Page
• Medical Devices & IVDs
  • IVD Guidance Documents

International Medical Device Regulators Forum (IMDRF)

• IMDRF Home Page
• Summary Technical Documentation (STED)
  • GHTF: Summary Technical Documentation (STED) for Demonstrating Conformity to the Essential Principles of Safety and Performance of In Vitro Diagnostic Medical Devices. 2011-03-17.
  • GHTF SG3: Implementation of risk management principles and activities within a Quality management System. 2005-05-20.

Conferences

• Medical Devices Conference™ Tools, Technologies and Strategies to Accelerate Your Time to Market
  http://www.devicestimetomarket.com/
• Software Design for Medical Devices
  http://www.sdmdconference.com/