Kiwa Dare Reviews & Capacity

Kiwa Dare Capacity

Waitlist for audits (updated 10/2022)

Kiwa Dare Reviews

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May 25, 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
1 months
Wait time before Techdoc audit
1 months
Wait time before QMS certificate
1 months
Wait time before Techdoc certificate
25000 €
Cost
incl. ncrs

I have no reference for medical regulatory pragmatic rating. Compared to space 9100 i would say this is not at all pragmatic.

Yes, I would choose this Notified Body again.
May 19, 2022

Review by company with 1-9 people

QMS audit done
Techdoc audit done
Overall experience
Well-organized / responsive
Regulatory pragmatism
Technical competence
4 months
Wait time before QMS audit
2 months
Wait time before Techdoc audit
2 months
Wait time before QMS certificate
1 months
Wait time before Techdoc certificate
23000 €
Cost
Application review (3000 euro); Year 1 audits (20000 euro); Surveillance audits (5000 euro); unannounced audits (7000 euro). Timelines and costs very clear up front.

Good communication, can call them with questions. Freelance auditor was good and had sufficient knowledge. Back and forth about significant/non-significant changes to certified product was good experience. They were quick to review and accept product changes.

Yes, I would choose this Notified Body again.