I have recently been asked for an opinion on design measures for a medical device design / manufacturer. As this is a favour I'd rather not go out and buy 13485 and thought I'd ask here - is there anything specific in the standard that a design department would need to consider as a measure of the design process?

I have recently been asked for an opinion on design measures for a medical device design / manufacturer. As this is a favour I'd rather not go out and buy 13485 and thought I'd ask here - is there anything specific in the standard that a design department would need to consider as a measure of the design process?

Hi Paul,

Look at this post + attachment (http://elsmar.com/Forums/showpost.php?p=216055&postcount=1) from Gert Sorensen. The left-hand column in the attachment contains the wording of ISO 13485. You may find what you're looking for. Hope this helps.

Stijloor.

Thanks, Stijloor. Thanks also to Gert Sorensen for a great bit of work - might even encourage me to get some work in the Medical Devices field! :lol:

might even encourage me to get some work in the Medical Devices field! :lol:

I don't want that on my conscience!! Don't come blaming me later! :D

I have recently been asked for an opinion on design measures for a medical device design / manufacturer. As this is a favour I'd rather not go out and buy 13485 and thought I'd ask here - is there anything specific in the standard that a design department would need to consider as a measure of the design process?You can follow the link to the standard.

http://learn.uci.edu/media/AR01/06011

Could someone remove this link as it points to copyrighted materials? Thanks!

Regarding the question on measures of design process, as ISo 13485 is based on the process-approach of ISO 9001 the concept of measures is the same, i mean, you have to measure all your process to guarantee that the outputs are verified and sometimes validated and in accordance with process inputs!

Could someone remove this link as it points to copyrighted materials? Thanks! Information posted on the internet is 'Fair Game' to be linked to. As long as the information its self is not posted on this site in full (and in this case it's only a link to that information), it's not a problem.

UCI.edu has made the decision to make this information public, so it's their issue to address. Should UCI decide they do not want the information available to the public, it is their responsibility to protect that information in some way such as putting the information in a non-public directory.

We do appreciate the 'heads up' however.

Thanks, Guys. Your help is much appreciated. :applause: :thanks:

The article is on the CQI web site here (http://newsweaver.co.uk/cqi/e_article000995103.cfm?x=bc11qlr,b80h29HK)
or within the cove here (http://elsmar.com/Forums/showthread.php?t=21817).

Nice response Paul, thanks.


I recently assisted a client who was struggling with the same kind of thing. As the audit dug a bit deeper, it was clear that:

a) they did research (aka mucking around in the lab, new product projects may or may not develop from there)

b) they did new product development

c) they did controlled changes to existing products.


All of these required different approaches, especially in relation to management oversight. After a few weeks they revamped their QMS to reflect these three different activities, and the management review/record-keeping that would need to apply.