Quality Management Systems – Medical Devices – Requirements for regulatory purposes

EN ISO 13485:2016

TUV HELLAS (TUV NORD) SA can offer accredited certification according to EN ISO 13485:2016, under its accreditation by ESYD as of 26 July 2018.

The application of the standard in design, production, sales, installation, technical support and decommissioning activities of medical devices ensures (partly) the compliance with the requirements of three current EU directives for the evaluation and CE marking.

TUV NORD CERT GmbH, member of TUV NORD GROUP, Notified Body for AIMD 90/385 and MDD 93/42 (0044), is accredited by DAKSS for EN ISO 13485:2016.

TUV NORD CERT GmbH, is also accredited by the “Standards Council of Canada“ (SCC), within the frame of the CMDCAS-Program („accepted Registrar”), for the CAN/CAS ISO 13485:2003, and since March 2017, is accredited according to new CAN/CAS ISO 13485:2016. Certification according to this standard by Accepted Registrars is a condition for the placement of medical devices on Canadian Market.

TUV NORD Inc. (TUV NORD GROUP) has been recognized as MDSAP Auditing Organization in summer 2018.

The publication of the New Regulations for Medical Devices (MDR 2017/745 and IVDR 2017/746), on 05 May 2017, repealing Directives AIMD 90/385, MDD 93/42 and IVDD 98/79, is expected to trigger the revision of EN ISO 13485:2016, so as to provide guidance on the respective MDR /IVDR requirements, covered by relevant clauses of EN ISO 13485. Also, there is a discussion on revision of EN ISO 13485:2016, according to the “High Level Structure” (under which several new or revised standards, like EN ISO 9001:2015 are already published).

The great experience of more than 20 years of the TÜV HELLAS auditors in the sectors of design, manufacturing, sterilization, standards management, application, usage and audits of medical devices, as well as the recognition and credibility of the TÜV NORD CERT GmbH certificates, offer added value to the companies that manufacture, trade and maintain medical devices.

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