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).
I am not a microbiologist but I play one on TV!
Medical device package validation is typically addressed separately from sterile barrier heat seal process validation. Want to save lots of money and time?