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What standards are required for medical device software?

Rami.Azulay March 2nd, 2011 Posted by Rami Azulay( ) 21 CFR part 820, IEC 62304, ISO 13485, ISO 14971

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.


About the author, Rami Azulay

Rami has over 24 years of experience in various software development and QA roles. Using his extensive knowledge of operations and quality, Rami was a main architect of the Orcanos software back in 2005 and later became Orcanos VP sales & marketing. Rami holds an MSC degree in Computer Sciences.

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