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!
C.
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!
C.