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IEC 62304

The international standard IEC 62304 – medical device software – software life cycle processes^[1] is a standard which specifies life cycle requirements for the development of medical software and software within medical devices. It is harmonized by the European Union (EU)^[2] and the United States (US),^[3] and therefore can be used as a benchmark to comply with regulatory requirements from both these markets.

Implications of IEC 62304 for software

The IEC 62304 standard calls out certain cautions on using software, particularly SOUP (software of unknown pedigree or provenance). The standard spells out a risk-based decision model on when the use of SOUP is acceptable, and defines testing requirements for SOUP to support a rationale on why such software should be used.^[4]

References

^ International Electrotechnical Commission (2006). "Medical device software – Software life cycle processes" (PDF). INTERNATIONAL IEC STANDARD 62304 First edition 2006-05. International Electrotechnical Commission. Retrieved 2 June 2012.
^ Staff (26 March 2012). "European standards Medical devices". European Commission. European Commission's Directorate General for Enterprise and Industry. Retrieved 2 June 2012.
^ Staff (20 August 2012). "Recognized Consensus Standards". FDA US Food and Drug Administration. US Department of Health & Human Services. Retrieved 26 January 2015.
^ Hall, Ken (June 1, 2010). "Developing Medical Device Software to IEC 62304". EMDT - European Medical Device Technology. Retrieved 2012-12-11.

External links

#62304 Category:Regulation of medical devices Category:Software development process Category:Medical software

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Klinische Bewertung

Anforderungen an die klinische Bewertung

Für die IVD Produkte fordert die Richtlinie 98/79/EG eine Leistungsbewertung statt einer klinischen Bewertung.

Klinische Daten und klinische Evidenz

Regulatorische Anforderungen an die klinische Bewertung

Umsetzung der Anforderungen uns Schnittstellen der klinischen Bewertung

Bezug zwischen Validierung und klinischer Bewertung

Neue Europäische Gesetzgebung

Die neuen Änderungen in der 2007/47/EC weist aus, dass alle implantierbaren und KLasse III Medizinprodukte einen Nachweis der klinischen Evidenz erbringen müssen.

Untergesetzliche Ebene

Die MEDDEV 2.7.1 bezieht sich auf die klinische Bewertung

SOUP Validierung

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IMDRF

Das INternational Medical Device Regulators Forum (IMDRF)

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[1] International Electrotechnical Commission (2006). "Medical device software – Software life cycle processes" (PDF). INTERNATIONAL IEC STANDARD 62304 First edition 2006-05. International Electrotechnical Commission. Retrieved 2 June 2012.

[2] Staff (26 March 2012). "European standards Medical devices". European Commission. European Commission's Directorate General for Enterprise and Industry. Retrieved 2 June 2012.

[3] Staff (20 August 2012). "Recognized Consensus Standards". FDA US Food and Drug Administration. US Department of Health & Human Services. Retrieved 26 January 2015.

[emdt-4] Hall, Ken (June 1, 2010). "Developing Medical Device Software to IEC 62304". EMDT - European Medical Device Technology. Retrieved 2012-12-11.

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