TÜV SÜD Product Service is the largest Medical Device Notified Body with accreditation for all medical devices and all conformity assessment routes.
With over 50 offices world-wide we provide a professional and responsive service to assist clients in bringing their products to market in compliance with international or national regulatory and voluntary requirements. Our range of services includes product testing, quality system assessments, medical evaluation of clinical data and expert evaluation of technical files for compliance with any or all CE marking regulations including certification to ISO 13485 / ISO 9001 and type testing. We provide globally respected compliance services for International Regulations including the USA (third party reviewer for 510k applications & a third party inspector for the FDA), Japan (Registered Certification Body under the Japanese Pharmaceutical Affairs Law) and Canada (accredited by Health Canada to issue ISO 13485 certificates required as part of the Canadian Medical Device Conformity Assessment Scheme).
In addition to all of the medical device related Directives, we are also a Notified / Competent Body for many other European Directives including the R&TTE, EMC and Low Voltage Directives.