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Notified Body

Berlin Cert (Germany)

CE 0633

Reviews of Berlin Cert, 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 done techdoc audit in progress

Wait times

QMS Audit: 6 months

QMS Certificate: 2 months

Techdoc Audit: pending

Techdoc Certificate: pending

Ratings

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

Audit Stage

only QMS Audit done, Risk Class 1 under MDD, thus no Techdoc necessary

Cost

9.000€ (only QMS audit)

Comment

they are very sceptical of GoogleDrive and GoogleDocs as QM system, but accepted it for the time being

March 1st, 2022

Small Company (<10 employees)

qms audit done techdoc audit done

Wait times

QMS Audit: 7 months

QMS Certificate: 2 months

Techdoc Audit: 3 months

Techdoc Certificate: 2 months

Ratings

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

Audit Stage

Got certification and had recertification after three years already

Cost

for MDD: 3.500€ per review, 5.000€ - 9.000€ per audit

Comment

LaGeSo is the worst...

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
Regulatory pragmatism
Technical competence

Comment on Why You Didn't Choose Them

Notified Body of a consulting customers. BerlinCert belongs to frech Afnor Group and will get MDR accreditation in Mai 2022. They Do active medical devices and samd. Good chances and vonpetent staff.

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