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.
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).
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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