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:

  • Conformance with IEC/ISO 62304 demonstrates to our customers that BrightInsight understands how to safely develop and maintain medical device software when the software is itself a medical device or when the software is an embedded or integral part of the final medical device.
  • This standard covers safe design and maintenance of software. It provides processes, activities, and tasks to ensure safety.
  • Our processes, documentation and quality culture have been audited independently in accordance with the IEC/ISO 62304 standard.
  • IEC/ISO 62304 is an FDA recognized consensus standard and is also recognized internationally.
  • BrightInsight’s agile software development process has been designed to meet the stringent requirements of IEC/ISO 62304 while continually improving its BrightInsight software.