Review Summary

3.7

Mediocre

• 6 reviews

Read all reviews

Overall experience: 3.7

Well-organized / responsive: 3.0

Regulatory pragmatism: 2.8

Technical competence: 3.5

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June 27, 2025

Review by company with 10-49 people

QMS audit done

Techdoc audit done

Overall experience

Well-organized / responsive

Regulatory pragmatism

Technical competence

3 Months Wait time before QMS audit

3 Months Wait time before Techdoc audit

14 Months Wait time before QMS certificate

2 Months Wait time before Techdoc certificate

100,000 € Approx. Cost (EUR)

Timeline

17 July 2023 – Contract signed with BSI
16 October 2023 – ISO 13485 first audit (completeness of SOPs)
22 January 2024 – Initial review of Technical Documentation completeness
13 February 2024 – ISO 13485 second audit (records review)
4 March 2024 – Technical Documentation review started
9 May 2024 – Our responses submitted for first round of queries
19 July 2024 – Our responses submitted for second round of queries
1 October 2024 – Our responses submitted for third round of queries
6 December 2024 – Certificate issued

Cost

We opted for the accelerated route, which increased the cost by almost three times compared to the standard timeline. We had technical review, clinical review and AI review (AI review also added extra cost to the process).
Total cost: ~ €100 000

Comments

BSI’s response times were excellent and their team was always available for meetings at our convenience. When our team was delayed in responding to Technical Documentation reviews due to summer holidays, BSI was very accommodating and didn't mind us submitting a bit later. Aside from the higher cost associated with the accelerated process, we have no negative feedback to share.

May 24, 2022

Review by company with 1-9 people

QMS audit done

Techdoc audit done

Overall experience

Well-organized / responsive

Regulatory pragmatism

Technical competence

? Wait time before QMS audit

? Wait time before Techdoc audit

6 Months Wait time before QMS certificate

? Wait time before Techdoc certificate

Not specified Approx. Cost (EUR)

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).

Additional Comments (Duration/Cost): Not sure how to answer that. The 13485 process seems appropriate but they always seem to add on 'extras' for this and that.

May 19, 2022

Review by company with 250+ people

QMS audit done

Techdoc audit done

Overall experience

Well-organized / responsive

Regulatory pragmatism

Technical competence

2 Months Wait time before QMS audit

3 Months Wait time before Techdoc audit

1 Month Wait time before QMS certificate

? Wait time before Techdoc certificate

40,000 € Approx. Cost (EUR)

May 05, 2022

Review by company with 10-49 people

QMS audit done

Techdoc audit done

Overall experience

Well-organized / responsive

Regulatory pragmatism

Technical competence

3 Months Wait time before QMS audit

3 Months Wait time before Techdoc audit

4 Months Wait time before QMS certificate

? Wait time before Techdoc certificate

50,000 € Approx. Cost (EUR)

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.

Additional Comments (Duration/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.)

March 21, 2022

Review by company with 250+ people

QMS audit done

Techdoc audit done

Overall experience

Well-organized / responsive

Regulatory pragmatism

Technical competence

12 Months Wait time before QMS audit

5 Months Wait time before Techdoc audit

6 Months Wait time before QMS certificate

3 Months Wait time before Techdoc certificate

Not specified Approx. Cost (EUR)

Additional Comments (Duration/Cost): It cost a fortune.

February 28, 2022

Review by company with 250+ people

QMS audit done

Techdoc audit done

Overall experience

Well-organized / responsive

Regulatory pragmatism

Technical competence

6 Months Wait time before QMS audit

? Wait time before Techdoc audit

5 Months Wait time before QMS certificate

? Wait time before Techdoc certificate

23,600 € Approx. Cost (EUR)

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

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".

Additional Comments (Duration/Cost): 13485 Recertification Audit will cost 7000 euro, yearly management fee 1400 euro. Stage 2 audit was 9700, CE Marking Application + ISO 13485 5500

BSI

6 Reviews

Timeline

Cost

Comments

SGS (Finland)

SIQ

SGS (Belgium)