Quality Assurance and Regulatory Requirements

EN ISO 13485 2016

Verifying that our products meet all specifications and quality requirements

Quality Assurance is important to us and we have a developed system to verify that our products and services meets the customers meets specifications and requirements of our customers.

Well documented and certificated in accordance with quality standards

Our quality system is well documented and we are certified in accordance with the standards required in the field. We also have the right to CE label our manufactured products in class I, IIa and IIb. We are certified by Intertek to ISO 13485, CMDCAS and EEC/MDD 93/42. We are also registered as manufacturer on many foreign markets, such as e.g. with the FDA in the US and Japanese Minister of Health, Labor and Welfare.

High quality, reliability and safety

Dentatus products are famous for their outstanding quality and reliability. We continuously strive to improve and monitor our product quality.
The regulatory requirements to which we comply with ensures that our products are safe to use and regularly controlled.

Certificates

ISO 13485:2016
ISO 13485:2016 CMDCAS
EC/MDD 93/42

Registration/accreditation numbers:

US Food and Drug Administration (FDA): 8030870
Health Canada: 122668
Japanese Minister of Health, Labor and Welfare: BG20300104

Download certificates here:

ISO 13485:2016 CMDCAS certificate (PDF)

ISO 13485:2016 certificate (PDF)

MDD certificate (PDF)

 

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