References

Glossary key term references are listed below.

Key Term References

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There are currently 57 references in this directory
Crossley, 2000
The Desk Reference of Statistical Quality Methods, Mark L. Crossley, ASQ Quality Press, Milwaukee, WI, 2000
EU IVDR 2017/746
In Vitro Diagnostic Medical Device Regulation

Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU
EU MDR 2017/745
Medical Device Regulation

Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
FDA 21CFR1
FDA 21CFR3
FDA 21CFR4
FDA 21CFR50
FDA 21CFR56
FDA 21CFR600
FDA 21CFR7
FDA 21CFR801
FDA 21CFR803
FDA 21CFR806
FDA 21CFR807
FDA 21CFR809
FDA 21CFR810
FDA 21CFR812
FDA 21CFR814
FDA 21CFR820
FDA 21CFR821
FDA 21CFR822
FDA 21CFR830
FDA 21CFR860
FDA 21CFR99
FDA guidance: Custom Device Exemption (2014)
FDA guidance: Deciding When to Submit...(2014)
FDA guidance: Design Control Guidance...(1997)
FDA guidance: Medical Device Accessories...(2017)
FDA guidance: Reprocessing Medical Devices...(2017)
FDA guidance: The 510(k) Program...(2014)
FDA website: Guide to Inspections of Quality Systems
FDA website: Medical Device Reporting (MDR)...
FDA website: Premarket Notification 510(k)
FDA website: Who Must Register...
IEC 60601-1:2012
IEC 60812:2006
IEC 61025:2006
IEC 62304:2015
IEC 62366-1:2015
IEC TR 60788:2004
IMDRF/SaMD WG/N10:2013
IMDRF/SaMD WG/N12:2014
Investopedia
ISO 10993-1:2018
ISO 11139:2018
ISO 13408-1:2015
ISO 13485:2016
ISO 14155:2020
ISO 14971:2019
ISO 15223-1:2016
ISO 17665-1:2006
ISO 20916:2019
ISO 31000:2018
ISO 9000:2015
ISO/TR 24971:2020
OLRC 21USC9
USPTO
  • US (FDA and OLRC) regulations, US FDA guidance documents, European (EU) regulations, and IMDRF documents are available online for free.
  • International (ISO and IEC) standards are available for purchase from ISO or IEC, and in some cases, a preview or read-only version may be available online for free.
    • American (US) versions of international medical device standards are available for purchase from AAMI which offers significant discounts for AAMI members.
    • Other national versions of international standards are available for purchase from national standards bodies.

For an introduction to medical device standards and regulations, view online video Course 250 – Regulatory Compliance.