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Notified Body

TÜV SÜD (Germany)

CE 0123

Reviews of TÜV SÜD, 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 6th, 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

Overall experience
Well-organized / responsive
Regulatory pragmatism
Technical competence

Comment on Why You Didn't Choose Them

too much work with not enough pay for them

March 4th, 2022

Mid-size Company (10-49 employees)

qms audit done techdoc audit done

Wait times

QMS Audit: 6 months

QMS Certificate: 4 months

Techdoc Audit: 3 months

Techdoc Certificate: 6 months

Ratings

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

Cost

27.000€

Comment on Duration and Cost

TÜV Prüfhaus was a life saver for our company. Auditor changed 3 times during initial processes.

Comment

The auditor changed so many times, prolonging processes. Different classifaction during this process for our products. Different time scales from different auditors. Billing with part bills that did not need to be paid.

March 3rd, 2022

Mid-size Company (10-49 employees)

qms audit done techdoc audit done

Wait times

QMS Audit: 9 months

QMS Certificate: 6 months

Techdoc Audit: 5 months

Techdoc Certificate: 0 months

Ratings

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

Cost

20.660,07€ (From Scratch to Market Ready)

February 28th, 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

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

Comment on Why You Didn't Choose Them

They did not even declined our request but just did not answer for 2 years

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