Kiwa Dare

Updated May 01, 2024

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2 Reviews

4.5 Good · 2 reviews

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Overall experience: 4.5

Well-organized / responsive: 4.0

Regulatory pragmatism: 4.0

Technical competence: 5.0

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: 0 Months
Wait time before Techdoc audit: 1 Month
Wait time before QMS certificate: 1 Month
Wait time before Techdoc certificate: 1 Month
Approx. cost (EUR): 25,000 €

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

Additional Comments (Duration/Cost): incl. ncrs

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

Wait time before QMS audit: 4 Months
Wait time before Techdoc audit: 2 Months
Wait time before QMS certificate: 2 Months
Wait time before Techdoc certificate: 1 Month
Approx. cost (EUR): 23,000 €

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.

Additional Comments (Duration/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.

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BSI

6 reviews · updated about 2 years ago

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SIQ

3 reviews · updated about 2 years ago

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Dekra (Netherlands)

5 reviews · updated about 2 years ago

Kiwa Dare

2 Reviews

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