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Notified Body

BSI (Netherlands)

CE 2797

Reviews of BSI, a Notified Body in Netherlands

These are user-submitted reviews of medical device companies describing their experience working with this notified body. This includes how well-organized the notified body was, technical proficiency of the auditor, wait times and cost.

Important Notes

Notified bodies typically work with many different auditors, some of which are freelancers. That's one of many reasons which may lead to strongly varying reviews of the same notified body.

And lastly: Even though some reviews may be negative, the goal is not to rant about notified bodies. We've built this to facilitate the sharing of information between Healthcare companies. The goal is to improve Healthcare by helping everyone bring medical devices to market in a safe, predictable, affordable and fair way.

As manufacturers get to choose their notified body, these reviews should help companies choose one which is fair, well-organized and technically competent.

May 24th, 2022

Mid-size Company (10-49 employees)

qms audit done techdoc audit in progress

Wait times

QMS Audit: pending

QMS Certificate: 6 months

Techdoc Audit: pending

Techdoc Certificate: pending

Ratings

Overall experience
Well-organized / responsive
Regulatory pragmatism
Technical competence
Would choose again: no

Cost

Not sure how to answer that. The 13485 process seems appropriate but they always seem to add on 'extras' for this and that.

Comment

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).

May 19th, 2022

Very large Company (250 employees or more)

qms audit done techdoc audit in progress

Wait times

QMS Audit: 2 months

QMS Certificate: 1 months

Techdoc Audit: 3 months

Techdoc Certificate: pending

Ratings

Overall experience
Well-organized / responsive
Regulatory pragmatism
Technical competence
Would choose again: no

Cost

40.000€

May 5th, 2022

Mid-size Company (10-49 employees)

qms audit done techdoc audit done

Wait times

QMS Audit: 3 months

QMS Certificate: 4 months

Techdoc Audit: 3 months

Techdoc Certificate: pending

Ratings

Overall experience
Well-organized / responsive
Regulatory pragmatism
Technical competence
Would choose again: yes

Cost

Around 50.000€

Comment on Duration and Cost

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.)

Comment

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

April 22nd, 2022

Mid-size Company (10-49 employees)

qms audit in progress techdoc audit in progress

Wait times

QMS Audit: pending

QMS Certificate: pending

Techdoc Audit: pending

Techdoc Certificate: pending

Ratings

Overall experience
Well-organized / responsive
Regulatory pragmatism
Technical competence

Comment

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

Comment on Why You Didn't Choose Them

They did not have capacity

March 21st, 2022

Very large Company (250 employees or more)

qms audit done techdoc audit done

Wait times

QMS Audit: 12 months

QMS Certificate: 6 months

Techdoc Audit: 5 months

Techdoc Certificate: 3 months

Ratings

Overall experience
Well-organized / responsive
Regulatory pragmatism
Technical competence
Would choose again: yes

Cost

a fortune

February 28th, 2022

Mid-size Company (10-49 employees)

qms audit in progress techdoc audit in progress

Wait times

QMS Audit: pending

QMS Certificate: 5 months

Techdoc Audit: pending

Techdoc Certificate: pending

Ratings

Overall experience
Well-organized / responsive
Regulatory pragmatism
Technical competence
Would choose again: yes

February 28th, 2022

Mid-size Company (10-49 employees)

qms audit in progress techdoc audit in progress

Wait times

QMS Audit: 3 months

QMS Certificate: pending

Techdoc Audit: pending

Techdoc Certificate: pending

Ratings

Overall experience
Well-organized / responsive
Regulatory pragmatism
Technical competence
Would choose again: yes

February 28th, 2022

Very large Company (250 employees or more)

qms audit done techdoc audit in progress

Wait times

QMS Audit: 6 months

QMS Certificate: 5 months

Techdoc Audit: pending

Techdoc Certificate: pending

Ratings

Overall experience
Well-organized / responsive
Regulatory pragmatism
Technical competence
Would choose again: yes

Audit Stage

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

Cost

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

Comment

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"

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