BSI (Netherlands)

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).

40.000€

Around 50.000€

response time is terrible, representative not replying to email or phone. (OpenRegulatory note: techdoc wait time was entered for each review round, and there were multiple rounds.)

9 month of constant nagging to become a customer. in the end daily phone-calls. had to wait four months from 13485 certification to receiving the certificate

Were not very friendly on the phone and re-scheduled our meeting 4 times...

They did not have capacity

a fortune

Other departments in our company handle Techdoc reviews, so we only have QMS certification

13485 Recertification Audit will cost 7000 euro, yearly management fee 1400 euro. Stage 2 audit was 9700, CE Marking Application + ISO 13485 5500

Compared to our company's corporate audits, which try to mimic an FDA audit, the BSI audits are pretty meek. Back in 2019 we used to get more findings, but ever since revamping our QMS the BSI audits tend to be a cake walk. Last year we got such a junior auditor, that he had trouble getting through all the material, that he really had to skim documents, those are the "best"