Certification IEC ISO 62304 2015

IEC/ISO 62304:2015

Medical device software life cycle processes.

The International Organization for Standardization (ISO) is an independent, non-governmental international organization with a membership of 163 national standards bodies.

The international standard IEC/ISO 62304 – medical device software – software life cycle processes 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) and the United States (US), and therefore can be used as a benchmark to comply with regulatory requirements from both these markets.

BrightInsight’s software development lifecycle process conforms with IEC/ISO 62304.

More information on this widely-recognized international standard:

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