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Notified Body

TÜV Rheinland (Germany)

CE 0197

Reviews of TÜV Rheinland, 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.

May 19th, 2022

Mid-size Company (10-49 employees)

qms audit done techdoc audit in progress

Wait times

QMS Audit: 5 months

QMS Certificate: 3 months

Techdoc Audit: 4 months

Techdoc Certificate: pending

Ratings

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

Cost

55.000€

Comment on Duration and Cost

Fixed times are not complied with

Comment

QMS audit and certification worked well. Technical Documentation is still pending for several months without any clear communication or time commitment from the auditor.

March 9th, 2022

Mid-size Company (10-49 employees)

qms audit done techdoc audit done

Wait times

QMS Audit: pending

QMS Certificate: 3 months

Techdoc Audit: 3 months

Techdoc Certificate: pending

Ratings

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

Cost

for MDR + 13485, approx 35.000€

Comment on Duration and Cost

if you are a long term customer and have a good relationship with the notified body, the cooperation can be uncomplicated. for new companies it is much more difficult i've heard and read.

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