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mdc medical device certification GmbH Niederlassung Berlin

Accredited by: DAkkS

mdc medical device certification GmbH Niederlassung Berlin is an accredited certification body operating under accreditation certificate D-ZE-16002-05-00, valid from May 27, 2024, to January 23, 2029, in accordance with DIN EN ISO/IEC 17065:2013. With locations in Stuttgart and Berlin, it conducts conformity assessment activities that comply with relevant standards and additional legal and normative requirements, including specific sectoral programs. The management system adheres to DIN EN ISO 9001 principles, and the certification services encompass various sectors, including orthopedic technology, orthopedic shoe technology, audiology, and optometry. Additionally, the organization provides prequalification services for service providers in accordance with § 126 SGB V (Social Code Book V).

https://www.mdc-ce.de/en/

Ernst-Augustin-Straße 2, 12489 Berlin, Germany

Certification Scopes (1)

ISO/IEC 17065

Certification Body for Products

Deutsche Akkreditierungsstelle GmbH

Germany

This scope is an annex to the accreditation certificate D-ZE-16002-05-00 according to DIN EN ISO/IEC 17065:2013, valid from 27.05.2024 to 23.01.2029. It is held by mdc medical device certification GmbH in Stuttgart and Berlin. The certification body complies with the standards to conduct conformity assessment activities listed in the annex. It also meets additional legal and normative requirements, including those in specific sectoral programs. The management system requirements align with DIN EN ISO 9001 principles. Certification services cover various sectors such as orthopedic technology, orthopedic shoe technology, audiology, optometry, and other supply areas. The abbreviations used refer to German Institute for Standardization (DIN), European Norm (EN), International Electrotechnical Commission (IEC), and International Organization for Standardization (ISO). The certification also includes services related to the prequalification of service providers according to § 126 SGB V (Social Code Book V).

Human health activities
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