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IEC 62304 for Medical Devices and IVD Vitro Diagnostics

IEC 62304 compliance

The IEC 62304 is an international standard outlining product life cycle processes pertaining to the development of software used with medical devices. It was developed by the International Electrotechnical Commission (IEC), an international organization that brings together professionals in the field of electric and electronic products, systems and services – collectively known as electrotechnology – for the purpose of standardizing electrotechnology.

International Electrotechnical Commission (IEC)

IEC 62304 is a safety standard that provides guidance on identifying hazards arising from software issues, in particular software in the category of SOUP (Software of Unknown Pedigree or Provenance). It acts as a guide for risk-control measures based on the software safety classification.
The standard details the QMS’s activities, processes, and tasks required when software is incorporated into a medical device, or if it functions as a stand-alone medical device (Software as a Medical Device or SaMD).

The extent of regulatory control over medical device software components is a derivative of its safety class according to IEC 62304, which is determined by the potential hazard each might pose:

ClassDescription
ANo injury or damage to health is possible
BNon serious injury is possible.
CDeath or serious injury is possible
class according to IEC 62304 - Gemarmed

How can we help?

GemarMed’s experts have proven experience in creating and maintaining a QMS for both medical device software products and medical devices in which are embedded software components. Our experts support software development teams from the get go so that processes comply with the IEC 62304 thereby minimizing the potential for expensive corrections.

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