November 17, 2022
Review by company with 50-249 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)
Our CE cert for class IIb will expire in April 2023; even if we went with our current company (Dekra Netherlands) the tech file review is estimated to take up to 8 months.
We are current clients of Dekra Netherlands (under MDD). The cost to review for MDR was nearly half a million. We are an $18M annual company and the cost was punitive. At this point we have no idea as to a way forward with MDR. No other companies answered our inquiries for MDR services.
We are current clients of Dekra Netherlands (under MDD). The cost to review for MDR was nearly half a million. We are an $18M annual company and the cost was punitive. At this point we have no idea as to a way forward with MDR. No other companies answered our inquiries for MDR services.