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NateDogg
Hi everyone,
I am curious to hear what other medical device professionals are considering Design Validation activities, and similarly which documents are being placed into the Design Validation part of a Design History File. This is focused on those activities other than Human Factors Engineering or Clinical Studies, which are more obviously part of Design Validation.
For example, would you consider Shipping Validation (to confirm that package contents are not damaged and that finished medical devices perform adequately following temperature and humidity conditions encountered during simulated or actual shipping processes) to be a Design Validation or Design Verification activity? Perhaps it can be both?
Would you consider Process Validation (to confirm a manufacturing process can produce a medical device that meets its specifications consistently) to be a Design Verification or Design Validation activity (or something else, perhaps a Design Transfer activity)?
I see various conventions in terms of where these activities fall in the design control process and where documents should go inside of the Design History File, so I appreciate any input on preferences and accompanying rationale from the forum. I prefer to follow a consistent approach, and I come across a lot of variations that I would like to harmonize in my work.
Thank you.
I am curious to hear what other medical device professionals are considering Design Validation activities, and similarly which documents are being placed into the Design Validation part of a Design History File. This is focused on those activities other than Human Factors Engineering or Clinical Studies, which are more obviously part of Design Validation.
For example, would you consider Shipping Validation (to confirm that package contents are not damaged and that finished medical devices perform adequately following temperature and humidity conditions encountered during simulated or actual shipping processes) to be a Design Validation or Design Verification activity? Perhaps it can be both?
Would you consider Process Validation (to confirm a manufacturing process can produce a medical device that meets its specifications consistently) to be a Design Verification or Design Validation activity (or something else, perhaps a Design Transfer activity)?
I see various conventions in terms of where these activities fall in the design control process and where documents should go inside of the Design History File, so I appreciate any input on preferences and accompanying rationale from the forum. I prefer to follow a consistent approach, and I come across a lot of variations that I would like to harmonize in my work.
Thank you.