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Notified Body

Kiwa Dare (Netherlands)

CE 1912

Reviews of Kiwa Dare, 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 25th, 2022

Small Company (<10 employees)

qms audit done techdoc audit done

Wait times

QMS Audit: 0 months

QMS Certificate: 1 months

Techdoc Audit: 1 months

Techdoc Certificate: 1 months

Ratings

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

Cost

25.000€ incl ncrs

Comment

I have no reference for medical regulatory pragmatic rating. Compared to space 9100 i would say this is not at all pragmatic

May 19th, 2022

Mid-size Company (10-49 employees)

qms audit done techdoc audit done

Wait times

QMS Audit: 4 months

QMS Certificate: 1.5 months

Techdoc Audit: 1.5 months

Techdoc Certificate: 0.5 months

Ratings

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

Cost

Application review (3000 euro); Year 1 audits (20000 euro); Surveillance audits (5000 euro); unannounced audits (7000 euro)

Comment on Duration and Cost

Timelines and costs very clear up front.

Comment

Good communication, can call them with questions. Freelance auditor was good and had sufficient knowledge. Back and forth about significant/non-significant changes to certified product was good experience. They were quick to review and accept product changes.

March 30th, 2022

Small Company (<10 employees)

qms audit in progress techdoc audit in progress

Wait times

QMS Audit: 2 months

QMS Certificate: pending

Techdoc Audit: pending

Techdoc Certificate: pending

Ratings

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

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