Seeking material on the Construction Process in IEC 62304



Hi Guys.

I´m a master degree student in biomedical engineering. I would ask for you a little help to guide me about the material I want to study to understand about the construction process of IEC 62304. (some books, articles, etc).

Thanks in Advance,

Diogo Rispoli


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A quick "Bump". My Thanks in advance to anyone who can help with this one.


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I did just a quick search for the standard and it is software for medical devices.

My thought is get the standard itself first and read through it. Make sure you understand best practices, such as may be described in the TickIT guide and consider best practices as you read the standard.

Make sure whether you need to look at other influences, such as (but not necessarily limited to) the US Food and Drug Administration (FDA).


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Apologies for the delay in replying, been busy...

When you say "the construction process of 62304" what, exactly do you mean? As Hershal pointed out, 62304 is a standard for medical device software (life cycle). If you are asking about the build (compilation) and release process, the standards are going to be pretty generic since Integrated Development Environments (IDEs) manage most of those processes. You'll only see references to configuration identification, configuration management, etc.

A good resource, IMO, for the software life cycle (in general) is the Capability Maturity Model Integration (CMMI) from the Software Engineering Institute at Carnegie Mellon (I have no affiliation with them). It goes into good depth on software processes, including Configuration Management.

If that's not what you meant by the construction process, maybe clarify your needs.
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