I have had several early-stage device company clients who are interested to get to “First In Man” (FIM) clinical use without breaking the bank. My job is to save the client enough money so they can pay my fee and have money left over for other things (like a great Christmas Party).
Much can be learned by reading “other Company” medical device labeling and promotional materials
I am not a microbiologist but I play one on TV!
Independence is the basis for judicial systems and sporting matches. And for quality systems, it is generally accepted that personnel who are independent of an activity are more objective (impartial) than persons who are directly responsible for the success of the work.
European Notified Bodies who are recognized by Health Canada should be on your short list.
Medical device package validation is typically addressed separately from sterile barrier heat seal process validation. Want to save lots of money and time? … Packaging Validation