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Notified Body

Dekra (Germany)

CE 0124

Dekra Capacity

Unknown

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Reviews of Dekra, a Notified Body in Germany

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.

March 21st, 2022

Review by small company (<10 employees)

qms audit in progress techdoc audit in progress

Wait times

QMS Audit: pending

QMS Certificate: pending

Techdoc Audit: pending

Techdoc Certificate: pending

Ratings

n/a
Overall experience
n/a
Well-organized / responsive
n/a
Regulatory pragmatism
n/a
Technical competence

Audit Stage

Reached out to learn about procedure.

Comment

They are fully booked until the end of 2022 and do not have a waiting list. We can contact them in Q4/22, then they will see if they have capacity for 2023 - but they rather do not expect it. To their knowledge, 15 out of 60 Notified Bodies are certified for MDR at the moment, even TÜV Nord is not MDR certified yet. That's so many customers that they can't be absorbed by the others. They hope that something will happen in the next 6 months, otherwise the ZLG will also have a real problem.

March 21st, 2022

Review by small company (<10 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
n/a
Regulatory pragmatism
n/a
Technical competence

Comment on Why You Didn't Choose Them

They said they are booked until the end of 2022 and we can call again THEN to see if they have any capacity in 2023, but they don't think so.

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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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