ISO 14971 (English Wikipedia)
Analysis of information sources in references of the Wikipedia article "ISO 14971" in English language version.
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cmtriallawyers.com
- Manookian, Brian. "Technical Information About ISO 14971". Cummings Manookian. Retrieved 13 September 2015.
europa.eu
eur-lex.europa.eu
- Council Directive 93/42/EEC of 14 June 1993
- Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices
- Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices
- REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017
- REGULATION (EU) 2017/746 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017
fda.gov
- "Applying Human Factors and Usability Engineering to Medical Devices" (PDF). U.S. Department of Health and Human Services Food and Drug Administration. February 3, 2016.
This article incorporates text from this source, which is in the public domain.
iso.org
- "FOREWORD - SUPPLEMENTARY INFORMATION". www.iso.org/foreword-supplementary-information.html.
- ISO Catalogue: Medical devices -- Application of risk management to medical devices
- "ISO/IEC Guide 51:2014 - Safety aspects -- Guidelines for their inclusion in standards". www.iso.org.
- "ISO/IEC Guide 63:2012 - Guide to the development and inclusion of safety aspects in International Standards for medical devices". www.iso.org.
- "ISO 14971:2019 Medical devices — Application of risk management to medical devices, the European Forward". www.iso.org. 14 July 2020.
- "Medical devices -- Application of risk management to medical devices". ISO. 2 May 2013. Retrieved 13 September 2015.
- "ISO/TR 24971:2013 - Medical devices -- Guidance on the application of ISO 14971". www.iso.org.
- "ISO/TR 24971:2020 - Medical devices -- Guidance on the application of ISO 14971". www.iso.org. 18 December 2019., the Forward