IEC 62304:2006 Medical device software - Software life cycle processes - Issued

W

wrodnigg

#1
Hello out there!

I just want to infom you, that the

IEC 62304:2006: Medical device software -- Software life cycle processes

was issued by 2006-05-17.

I think it is a good guideline for medical device software development.

And since the the MDD draft contains a requirement for MD software life cycle management, I am rather sure, this standard will be harmonized soon...

~ghw
 
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amjadrana

Involved - Posts
#2
Iec 62304

I have read the preview of the standard available at the following website. It seems to be a requirements standard and not just a guidance standard. It relies heavily on ISO 14971 and the quality management system (ISO 13485). It means that the madical device software development could be assessed internally or externally to this standard.

http://domino.iec.ch/preview/info_iec62304{ed1.0}b.pdf

I wonder, whether this standard shall become part of IEC 60601-1 third edition.

Amjad Rana
 
W

wrodnigg

#3
I think it would have been to much, integrating it into the 3rd edition. The 3rd edition has a wider scope and is thick enough. The 60601-1-4 has been integrated into the 3rd edition.

And yes, it could be a basis for an assessment. But as long as it is not harmonized with the directives (it can be applied on AIMD, MDD and IVDD) it is not a mandatory requirement.

~ghw
 

apestate

Quite Involved in Discussions
#4
Is that how the standard would be come third party assessable, i.e. for registration, by harmonization with international directives?

What would put this standard into the 3rd party auditing world?
 
W

wrodnigg

#5
To my opinion, an IEC 62304 would not be very useful, since a manufacturer needs MDD or IVDD certification. Maybe it could be useful for contract manufacturers, but also in this case 13485 certification would be better.

I am still waiting for my copy of the final standard. On the first pages, there should be valuable informations on the scope and other regulatory topics.

~ghw
 
A

alicecbrown

#6
Thanks for the knowledge. Just found out we have a copy here that I am reading in preparation for a course next week. Any problems with it so far, in terms of actual applicability? sometimes standards need a little real-life feedback (e.g. the translation from Dod-2167 to Dod-2167A.)
 

Coury Ferguson

Moderator here to help
Staff member
Super Moderator
#7
Thanks for the knowledge. Just found out we have a copy here that I am reading in preparation for a course next week. Any problems with it so far, in terms of actual applicability? sometimes standards need a little real-life feedback (e.g. the translation from Dod-2167 to Dod-2167A.)
This thread is 2 years old. You may want to start a new one. Just a suggestion.
 
M

MIREGMGR

#9
Start at the front page. Review the various forums and sub-forums, and choose the one that's most on point for your topic. Go to that forum. You now should see a list of existing threads. Depending on how busy your sub-forum is, you may want to do a search, either brute force or by search tools, of whether someone else has recently discussed your topic. If your topic is novel, proceed to your post; there should be a New Thread button in the upper left quadrant of the page display.
 
D

DoyleNxStage

#10
Does anyone know the Date of cessation of presumption of conformity of superseded standard EN62304???
 
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