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Notified Body

DQS (Germany)

CE 0297

Reviews of DQS, 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.

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.

March 21st, 2022

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 have to check the capacity on a case-by-case basis, so we have to request a quote for that. If we get one and place the order, we get an account manager who organizes the auditors. Then our TD is subjected to a preliminary audit - only if this goes well do we get a certification contract. Background: with MDR there are only three attempts for TD testing, then the process has to be restarted.

March 16th, 2022

Large Company (50-249 employees)

qms audit done techdoc audit done

Wait times

QMS Audit: 6 months

QMS Certificate: pending

Techdoc Audit: 6 months

Techdoc Certificate: pending

Ratings

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

Cost

30.000€

February 28th, 2022

Mid-size Company (10-49 employees)

qms audit done techdoc audit done

Wait times

QMS Audit: 6 months

QMS Certificate: 3 months

Techdoc Audit: 5 months

Techdoc Certificate: 2 months

Ratings

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

Cost

10.000€

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