Impartiality and independence

Kiwa Assurance B.V. operates independently within Kiwa NL Holding B.V. We are financially self sufficient and derive our revenue exclusively from services provided to our clients. Our standard fees are presented in the fee schedule provided below. These arrangements ensure our certification activities remain free from any commercial, financial, or other influences that could affect our impartiality.

In accordance with ISO/IEC 17021-1 and Regulation (EU) 2017/745 (MDR), Kiwa Assurance B.V. does not offer or engage in any form of consultancy related to the design, manufacture, marketing, installation, use or maintenance of medical devices. This includes, but is not limited to, any advisory services that could compromise our role as an independent third-party conformity assessment body. This strict separation of certification and consultancy activities is essential to uphold the impartiality, objectivity and integrity of our assessments, as required under MDR Annex VII, Section 1.2.3 and ISO/IEC 17021-1.

Our commitment to impartiality is further supported by robust internal procedures, oversight mechanisms and a declarations of impartiality.

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Kiwa Medical Device Certification

Medical devices placed on the European market must comply with the Medical Device Regulation (EU) 2017/745 (MDR). This regulation ensures that devices meet high standards of safety and performance.

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