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Kiwa Dare

Updated May 01, 2024

No additional description provided for this Notified Body.

2 Reviews

Review Summary

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

0 Months Wait time before QMS audit

1 Month Wait time before Techdoc audit

1 Month Wait time before QMS certificate

1 Month Wait time before Techdoc certificate

25,000 € Approx. Cost (EUR)

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

4 Months Wait time before QMS audit

2 Months Wait time before Techdoc audit

2 Months Wait time before QMS certificate

1 Month Wait time before Techdoc certificate

23,000 € Approx. Cost (EUR)

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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2 Reviews

DQS

BSI

SIQ