QA Standards for IEC 62304

by itsbusiness AG

Across industries, standards are an important way to safeguard product conformity while simultaneously harmonizing requirements both nationally and internationally. Quality assurance is vital to ensure that the producer correctly applies standards.

IEC 62304 is the international standard which specifies life cycle requirements for the development of medical software and software within medical devices.

IEC 62304 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.

SOUP

The IEC 62304 standard calls out certain cautions on using software, particularly SOUP (Software of Unknown Provenance). The standard spells out a risk-based decision model on when the use of SOUP is acceptable and defines testing requirements for SOUP to support a rationale on why such software should be used.

For more information on SOUP, see the Johner Institute blog post soup-and-ots.

Risk Classification

This standard has the following impact on Software Quality: The Software Lifecycle Process must be followed according to risk classification(visit /safety-classes-level-of-concern/ for more information):

  • Class A if the software system cannot contribute to a hazardous situation; or the software system can contribute to a hazardous situation which does not result in unacceptable risk after consideration of risk control measures external to the software system.
  • Class B if the software system can contribute to a hazardous situation which results in unacceptable risk after consideration of risk control measures external to the software system and the resulting possible harm is non-serious injury.
  • Class C if the software system can contribute to a hazardous situation which results in unacceptable risk after consideration of risk control measures external to the software system and the resulting possible harm is death or serious injury.
Software documentation Class A Class B Class C
Software development planning X X X
Software requirements analysis X X X
Software architectural design   X X
Software detailed design     X
Software unit implementation X X X
Software unit verification   X X
Software integration and integration testing   X X
Software system testing   X X
Software release X X X

Safety Classification for IEC 62304 Development Process

Support from itsbusiness AG

With our experienced consultants, including staff who have developed and tested safety critical software, itsbusiness supports you in the development of robust software quality assurance, carries out an assessment together with you for a TARGET/ACTUAL analysis, and submits an action plan as well as for the implementation. Within the scope of the implementation, we support you in the implementation of the action plan and ensure the achievement of the objectives.

Contact

If you have questions or need more information, please contact:

Andrew Connell
QA Consultant, itsbusiness AG
+41 31 370 32 05
andrew.connell@itsbusiness.ch​

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