Darrin Carlson
Registered
Hi all,
Now that we have had a month to soak in the QMSR, how's everyone feeling about getting this implemented by February 2026?
I'm worried FDA investigators are going to be more exacting than a NB auditor (especially since they will be newer to ISO 13485), so I want to have all my ducks in a row and not rest on a general "no substantive impact" statement.
The only thing really standing in my way is finding all the time to get this comprehensive assessment in place!
Now that we have had a month to soak in the QMSR, how's everyone feeling about getting this implemented by February 2026?
- What are your goals?
- What are you worried about?
- What barriers are you facing?
I'm worried FDA investigators are going to be more exacting than a NB auditor (especially since they will be newer to ISO 13485), so I want to have all my ducks in a row and not rest on a general "no substantive impact" statement.
The only thing really standing in my way is finding all the time to get this comprehensive assessment in place!