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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

Review Summary

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

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

6 Months Wait time before QMS audit

? Wait time before Techdoc audit

2 Months Wait time before QMS certificate

? Wait time before Techdoc certificate

9,000 € Approx. Cost (EUR)

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.

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

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

7,000 € Approx. Cost (EUR)

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.

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

Not specified Approx. Cost (EUR)

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.

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3 Reviews

SGS (Belgium)

SGS (Finland)

BSI