Berlin Cert

Updated August 06, 2024
Berlin Cert is a Notified Body in Germany and quite popular among startups which develop software as a medical device.

3 Reviews

4.7 Very good · 3 reviews
Read all reviews
Overall experience
4.7
Well-organized / responsive
4.7
Regulatory pragmatism
4.7
Technical competence
4.3
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March 21, 2022

Review by company with 1-9 people

QMS audit done
Techdoc audit done
Overall experience
Well-organized / responsive
Regulatory pragmatism
Technical competence
Wait time before QMS audit
6 Months
Wait time before Techdoc audit
?
Wait time before QMS certificate
2 Months
Wait time before Techdoc certificate
?
Approx. cost (EUR)
9,000 €
Only QMS Audit done, Risk Class 1 under MDD, thus no Techdoc necessary. They are very sceptical of GoogleDrive and GoogleDocs as QM system, but accepted it for the time being.

Additional Comments (Duration/Cost): Cost only includes QMS audit.

Yes, I would choose this notified body again.

March 01, 2022

Review by company with 1-9 people

QMS audit done
Techdoc audit done
Overall experience
Well-organized / responsive
Regulatory pragmatism
Technical competence
Wait time before QMS audit
7 Months
Wait time before Techdoc audit
3 Months
Wait time before QMS certificate
2 Months
Wait time before Techdoc certificate
2 Months
Approx. cost (EUR)
7,000 €
Got certification and had recertification after three years already.

LaGeSo is the worst...

Additional Comments (Duration/Cost): For MDD: 3.500€ per review, 5.000€ - 9.000€ per audit.

Yes, I would choose this notified body again.

February 28, 2022

Review by company with 1-9 people

QMS audit done
Techdoc audit done
Overall experience
Well-organized / responsive
Regulatory pragmatism
Technical competence
Wait time before QMS audit
?
Wait time before Techdoc audit
?
Wait time before QMS certificate
?
Wait time before Techdoc certificate
?
Approx. cost (EUR)
Not specified
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 competent staff.
Yes, I would choose this notified body again.

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