MD Design and development procedure


Starting to get Involved
Hi eveyone,
I'm dealing with the company's quality management system and the recertification of products from MDD to MDR.
I would like some help with the design and development phase of a medical device as described by the standard 13485. Do you have an example of a standard procedure covering D&D that I can look at so that I can understand how to set it up? I have only been dealing with these aspects for a short time and they are still not completely clear to me....
many thanks!


Super Moderator
The standard was harmonized under both MDD and MDR (I think) so there's really no change there.

Folks are likely unwilling to part with an entire SOP plus you might get something that's not particularly applicable to your company! If you have specific questions about the application, you're more likely to get good responses.
Top Bottom