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Notified Body

Dekra (Netherlands)

CE 0344

Dekra Capacity

Declining new customers

Last tried 10/2022

Reviews of Dekra, 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.

November 17th, 2022

Review by large company (50-249 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

Our CE cert for class IIb will expire in April 2023; even if we went with our current company (Dekra Netherlands) the tech file review is estimated to take up to 8 months.

Comment on Why You Didn't Choose Them

We are current clients of Dekra Netherlands (under MDD). The cost to review for MDR was nearly half a million. We are an $18M annual company and the cost was punitive. At this point we have no idea as to a way forward with MDR. No other companies answered our inquiries for MDR services.

May 26th, 2022

Review by mid-size company (10-49 employees)

qms audit done techdoc audit done

Wait times

QMS Audit: 3 months

QMS Certificate: 2 months

Techdoc Audit: 1 months

Techdoc Certificate: 2 months

Ratings

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

Comment on Duration and Cost

MDD class IIa

May 25th, 2022

Review by mid-size company (10-49 employees)

qms audit done techdoc audit done

Wait times

QMS Audit: 4 months

QMS Certificate: pending

Techdoc Audit: pending

Techdoc Certificate: 5 months

Ratings

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

Cost

20.000€

Comment on Duration and Cost

costs are artificially raised by strange and noncompliances extra reviews

Comment

during last audit a major noncompliance was raised but they only would see their answer and didn't response on any counterarguments (inclusing paragaphs out their own manual) leading to unnescessary delay and unreleated extra review times

February 28th, 2022

Review by mid-size company (10-49 employees)

qms audit in progress techdoc audit in progress

Wait times

QMS Audit: 7 months

QMS Certificate: pending

Techdoc Audit: pending

Techdoc Certificate: pending

Ratings

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

Comment

I’ve worked with Dekra in a previous job as well. Sometimes it felt as if we were paying them for consultation rather than an audit. I certainly did not feel like I needed to hide things from them.

February 28th, 2022

Review by large company (50-249 employees)

qms audit done techdoc audit done

Wait times

QMS Audit: 6 months

QMS Certificate: pending

Techdoc Audit: 8 months

Techdoc Certificate: 2 months

Ratings

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

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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.

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