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Notified Body

Medcert (Germany)

CE 0482

Medcert Capacity

Audits in 6-12 months

Last tried 06/2022

Reviews of Medcert, 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

Website does not yet contain any references to MDR, but according to phone call (and ZLG list) they are allowed to certify according to MDR. Person on the phone was very confused and imprecise. We can make an inquiry, this will be answered by the managing director, but this will take some time. They have very many existing customers who come first, they do not know if they have capacity for new customers currently.

March 3rd, 2022

Review by mid-size company (10-49 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

N/A - Only asked for offer on the phone, simply got laughed at that I wanted to be a client

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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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