Design Control SOP - Streamlining with R&D Department

K

kennethmabou

#1
Hi folks.

I'm a newly registered user of the forum and fairly new to the Quality realm. I was looking for tips or samples of SOPs for Design Control (7.3 of ISO-13485) which are more user-friendly for R&D types.

Our company uses an off-the-shelf SOP which is too cumbersome to be of much practical use. Any ideas or samples would be very much appreciated!!

:thanx:
 
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K

kennethmabou

#3
Thanks. It is a small medical device manufacturer. We have several products on the market and a small R&D team developing enhanced products based on customer and market feedback and new products based on the same.
 

sagai

Quite Involved in Discussions
#4
I do not believe in golden template.
I would suggest, to interpret what is in the standard according to your view and, well, write it down, review with expert and let it go.
Really, I do not think there would be any template you could use.
Alternative is to hire a consultant for this job. Could be a weekly cost as far as I would commit (but I can not, anyway).
Regards!
 
K

kennethmabou

#5
Thanks again. I am doing that. I'd just like to get some ideas and useful templates from others if possible, to incorporate into our own.
 
#6
I have moved this post to ISO 13485 and ISO 14969 - Medical Devices - Quality Management Systems sub-forum, for better hits and responses ....
 

sagai

Quite Involved in Discussions
#7
Well, I guess you ask it with reason, if there is any concern you have or specific uncertainty, just let us know.
 
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