IEC 62304 -standard

IEC 62304 defines the set of processes for life-cycle management of medical device software.

What is IEC 62304?

IEC 62304 defines the set of processes for life-cycle management of medical device software:

  • Software development process
  • Software maintenance process
  • Software risk management process (together with ISO 14971)
  • Software configuration management process
  • Software problem resolution process

The standard is applicable for all medical devices that include software (driving or influencing) and to softwares that itself are medical devices i.a. Medical device softwares.

IEC 62304 is commonly used together with the quality management system standard ISO 13485 and the risk management standard ISO 14971 for medical devices and fulfills the requirements set in e.g. MDR.

Kasve has extensive experience in planning, development, implementation and management of software development processes that fulfills the IEC 62304 requirements. Kasve also supports customers in creating a requirement fulfilling software development platform and document environment that automatically fulfills the requirements set in the standard.

IEC/EN 62304 Workshops and Training

The workshop involves presenting the main features of the product development of medical software and the IEC/EN 62304 standard to the extent that corresponds to the client’s needs.

Software Development Tools

A turnkey solution for project and knowledge management in medical software product development. The Medical Device Project Management Kit is based on widely used tools.

Product Development Health Check

The Product Development Health Check will ensure that your product development project is appropriate and fulfils requirements.

Other standards

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