07.16 Certification and testing of medical devices, quality assurance
Certification and testing of medical devices, quality assurance
Product category: Technical equipment management, test houses / certification bodies
TÜV SÜD Product Service
As the worlds 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 manufacturers quality management systems that will satisfy some requirements of the regulatory authorities of each participating country.