U.S. Food and Drug Administration
- FDA Home Page
- Design Control
- 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.
- Human Factors
- FDA: Draft Guidance for Industry and Food and Drug Administration Staff – Applying Human Factors and Usability Engineering to Optimize Medical Device Design. 2011-06-22.
- 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- Molly Follette Story, PhD, FDA: Human Factors Draft Guidance Document: Agency Expectations for Human Factors Data in Premarket Submissions (Presentation at AAMI/FDA International Conference on Medical Device Standards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
- 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Determining Substantial Equivalence in Premarket Notifications [510(k)] with Different Technological Characteristics – Draft Guidance for Industry and Food and Drug Administration Staff. 2014-07-15.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 standards – Active implantable medical devices
- European standards – In vitro diagnostic medical devices
- European standards – Medical devices
- 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
Therapeutic Goods Administration (TGA), Australia
International Medical Device Regulators Forum (IMDRF)
- IMDRF Home Page
- Summary Technical Documentation (STED)