Understanding The Role Of IEC 62304 in Medical Device Software Development


One of the major reasons behind the growth of medical sector is the integration of advanced software with the medical devices. These software are used as an integral component of a medical device, application on mobile, or in a standalone device used in health care treatment or diagnosis. However, to ensure that the software build by medical device software companies is safe and reliable for users, it needs to follow an international standard. IEC 62304 (medical device software) for software life cycle processes is a standard given by both European and the US authorities that specifies life cycle requirements for the development of a medical software.

Software development companies use this standard as a benchmark to comply with regulatory requirements and deliver competent medical device software. IEC 62304 standard needs to be applied while building a medical device software which is itself a medical device, or the development of a software that will be integrated into medical devices.

Complying with IEC 62304 Safety Standards

To ensure the developed medical software is suitable and beneficial for users, the authorities have added safety standards to IEC 62304. To comply with the safety standard, the entire software development process needs to be well-documented. With the help of advanced software development tools, you can easily document and accelerate compliance.

Safety standard processes under IEC 62304
  • Scope
  • Normative References
  • Terms and definitions
  • General requirements
  • Software development process
  • Software maintenance process
  • Software risk management process
  • Software configuration management process
  • Software problem resolution process
Under the software development part of the safety measures, the companies need to follow eight stages and document every detail of each stage of the development process.
  • Software development planning
  • Software requirements analysis
  • Software architectural design
  • Software detailed design
  • Software unit implementation and verification
  • Software integration and integration testing
  • Software system testing
  • Software release
The safety standards help companies ensure they are taking the mandatory precautions for building an effective medical device software. So, while searching for the best medical device software development companies, make sure you consider IEC 62304 as an essential factor

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