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We are an early stage medical device company that will be aiming for 13485 certification soon. We have implemented a paper based quality system and are in the Concept/Feasibility stage of Design Control.
Are there any guidelines for type of content to be included or excluded, i.e. facts, opinions etc.?
-Specifically pertaining to meeting with physicians who provide input to design concepts, comment on user needs, and potential risks and hazards.
-Also for meetings with engineers discussing design concepts
What should we include/exclude in terms of content?
Thanks!
Are there any guidelines for type of content to be included or excluded, i.e. facts, opinions etc.?
-Specifically pertaining to meeting with physicians who provide input to design concepts, comment on user needs, and potential risks and hazards.
-Also for meetings with engineers discussing design concepts
What should we include/exclude in terms of content?
Thanks!