May 24th, 2022
Review by mid-size company (10-49 employees)
QMS Audit: pending
QMS Certificate: 6 months
Techdoc Audit: pending
Techdoc Certificate: pending
Not sure how to answer that. The 13485 process seems appropriate but they always seem to add on 'extras' for this and that.
The problem is that they seem to use contractors and who they send is random. When we got started with them originally the person they sent was amazing (5+/5) and they came for the first few times. After that apparently, he cost too much and they started sending random contractors who were more focused on minor gotchas than adding any real value (i.e. regulatory pragmatism as you put it earlier).