TÜV SÜD Product Service GmbH of München at MEDICA 2018 in Düsseldorf -- MEDICA - World Forum for Medicine
Service

TÜV SÜD Product Service GmbH

Ridlerstr. 65, 80339 München
Germany
Telephone +49 89 50084747
Fax +49 89 51551202
meineanfrage@tuev-sued.de

Hall map

MEDICA 2018 hall map (Hall 10): stand C12

Fairground map

MEDICA 2018 fairground map: Hall 10

Our range of products

Product categories

  • 07  Medical Services and Publications
  • 07.04  Education

Education

  • 07  Medical Services and Publications
  • 07.15  Technical equipment management, test houses / certification bodies

Technical equipment management, test houses / certification bodies

  • 07  Medical Services and Publications
  • 07.16  Certification and testing of medical devices, quality assurance

Certification and testing of medical devices, quality assurance

Our products

Product category: Technical equipment management, test houses / certification bodies

TÜV SÜD Product Service

As the world’s largest EU Notified Body for all types of medical devices covered by EU directives and regulations, TÜV SÜD Product Service is prepared and working closely with the Authorities to get notification as a Notified Body under the new MDR and IVDR. Under the new regulations, stricter requirements will be imposed on Notified Bodies and all existing Notified Bodies will have to receive new notification. Therefore, it is essential for manufacturers to have a Notified Body who will retain their status after the new regulations take effect.

Medical device manufacturers are faced with increased product development costs and time-to-market challenges as they must apply for testing and certification with different Certification Bodies to gain access to individual export markets. A globally consistent approach to the auditing and monitoring of medical device manufacturing is needed to minimise burdens and eliminate redundancy, while improving safety and efficacy.

The Medical Device Single Audit Program (MDSAP) allows authorised auditing organisations to conduct a single audit of a manufacturer’s quality management systems that will satisfy some requirements of the regulatory authorities of each participating country.

More Less