Berlin Cert Reviews & Capacity

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

Berlin Cert Capacity

Audits in 3-6 months (updated 10/2022)

Berlin Cert Reviews

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March 21, 2022

Review by company with 1-9 people

QMS audit done
Techdoc audit not done yet
Overall experience
Well-organized / responsive
Regulatory pragmatism
Technical competence
6 months
Wait time before QMS audit
?
Wait time before Techdoc audit
2 months
Wait time before QMS certificate
?
Wait time before Techdoc certificate
9000 €
Cost
Cost only includes QMS audit.

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.

Yes, I would choose this Notified Body again.
March 1, 2022

Review by company with 1-9 people

QMS audit done
Techdoc audit done
Overall experience
Well-organized / responsive
Regulatory pragmatism
Technical competence
7 months
Wait time before QMS audit
3 months
Wait time before Techdoc audit
2 months
Wait time before QMS certificate
2 months
Wait time before Techdoc certificate
7000 €
Cost
For MDD: 3.500€ per review, 5.000€ - 9.000€ per audit.

Got certification and had recertification after three years already.

LaGeSo is the worst…

Yes, I would choose this Notified Body again.
February 28, 2022

Review by company with 1-9 people

QMS audit not done yet
Techdoc audit not done yet
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
?
Cost

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.