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Posts tagged "IEC 62304"

What standards are required for medical device software?

March 2nd, 2011 Posted by 21 CFR part 820, IEC 62304, ISO 13485, ISO 14971 0 thoughts on “What standards are required for medical device software?”

There are lots of standards, and I sometimes find it confusig, where people dont really know what is the acceptable standard for software lifecycle in medical device, acceptable by the FDA and CE. Some vendors also claim t support specific standards, such as 21CFR 820, which has nothing to do with softwaare lifecycle in specific.

I came to the final conclusion:

The acceptable standard for software lifecycle management is IEC 62304, you can find some data about it in this blog

The ISO 14971 talks about risk management

The 21 CFR part 820 is more or lessthe same as ISO 13485 and they don’t talk about software lifecycle in particular (see this link for reference: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?cfrpart=820 ). The software lifecycle is only one part.

The FDA guidelines for software lifecycle managemnt are specified in the General Principles of Software Validation, and they are very hard to understand. Thats why it is recommended to use the IEC 62304 guidelines.

IEC 62304 For Software Lifecycle In Medical Device

February 22nd, 2011 Posted by IEC 62304, Validation and Verification 0 thoughts on “IEC 62304 For Software Lifecycle In Medical Device”

IEC 62304 (and EN 62304) is the international standard for software life cycle for medical device. IEC 62304 specifies life cycle requirements for the development of medical software and software within medical devices. It is harmonized by the European Union and the United States. Compliance with this standard fulfills the FDA 21 CFR820 requirements as well as the Medical Device Directive 93/42/EEC.

Main activities described in IEC 62304 that are fully supported in QPack

  • Requirements traceability
  • Integrated risk management process
  • Test Management (Unit/Module/Integration/System)

See QPack main features

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