Design and Development Process - Does one size fit all?

Mark Meer

Trusted Information Resource
We've drawn inspiration from the IEC60601 series. That is, have a general procedure, and supplementary procedures for specific project types that either modify, add to, or supersede the general procedure.

Could you perhaps develop a generalized design and development procedure that defines requirements for all D&D, regardless of the project. This should be kept as general as possible, so as to not prescribe unnecessary burdens for simple projects.

Then include a supplementary procedure, something like "particular requirements for medical device design & development", that specifies additional requirements for your IVDD products.

This way, your veterinary product would just be under the scope of the general procedure, whereas your IVDD product would be subject to both.
 
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