Software Validation Requirements for Class I Active Medical Device

A

Arnthor

#1
Dear all,

My company is going to manufacture a class I active medical device which have software in it.

This is the first time my company is manufacturing an active medical device with software.

Can anybody advice how to perform software validation?

I am aware there is a guidance doc from US FDA on software validation. Does EU have a similar guidance doc?

Best regards,

Arnthor
 
Elsmar Forum Sponsor

Stijloor

Staff member
Super Moderator
#2
Dear all,

My company is going to manufacture a class I active medical device which have software in it.

This is the first time my company is manufacturing an active medical device with software.

Can anybody advice how to perform software validation?

I am aware there is a guidance doc from US FDA on software validation. Does EU have a similar guidance doc?

Best regards,

Arnthor
Can someone help?

Thank you!!

Stijloor.
 
W

wrodnigg

#3
Within the EU regulation there is the harmonized standard EN 62304 "Medical device software - Software life-cycle processes", which does not include aspects of software validation (this is excluded in the scope of the standard).

Validation is the topic of clause 7.3.6 of the ISO 13485 standard.

To answer your question: There is no specific guidance doc for medical device software validation, the FDA guidance is pretty fine. Or just apply the (simple) V-Model on software validation.
 

v9991

Trusted Information Resource
#4
Since you indicated that you are getting into the area for for first time; its appropriate to gain knowledge as much as possible to understand the requirements/practices;

Just in case if you have not already seen these...

Eudralex : Annex 11: Computerised Systems
http://ec.europa.eu/health/files/eudralex/vol-4/annex11_01-2011_en.pdf

General Principles of Software Validation; Final Guidance for Industry and FDA Staff
http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm085281.htm

and most widely practiced/accepted model of implementation is ISPE's GAMP Guidance;

+ have a look at "similar discussion threads" at end of your post

also enclosing Good Practices for computer systems in Regulated GxP Environments
 

Attachments

c.mitch

Quite Involved in Discussions
#5
Hello arnthor,

If you know the FDA good practices on software, aka GPSV, you can use them for CE mark. They're much stronger than what is required for class I devices in EC.
For class I software, you should follow a design process but it's not necessary to do "high level" tasks, around coding, like auto tests, code reviews and static analysis.
Documents proving that you did follow a process with specifications, conception, coding and tests is enough. All of this with risk analysis, of course.

If you want explanations on how software classification works for EC, please have a look at this article I wrote: http://blog.cm-dm.com/post/2011/11/04/How-to-classify-and-CE-mark-software

Regards,

Mitch.
 
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