TÜV SÜD America - Medical Device Compliance, Testing and Consultancy Services

TÜV SÜD America, a subsidiary of TÜV SÜD, the largest of the German TÜVs, is a leading technical services company active in the industry, product and transport sectors. Its range of services encompasses consultancy, inspections, test and expert opinions as well as certification and training. TÜV SÜD America has more than 750 experts in over two dozen locations throughout the US, Canada and Mexico.

Consultancy, testing and inspection services

TÜV SÜD is an nationally recognized testing laboratory (NRTL) and SCC certified. Services include CE Marking assistance, electromagnetic compatibility (EMC), electrical and mechanical testing, and many additional global conformity assessment services helping companies gain product compliance to enter international markets.

Medical device compliance services

Achieving success in global markets requires gaining rapid market entry for your medical device products. The Medical Health Services unit of TÜV Product Service offers a variety of global compliance services that help ensure your products' acceptance and success.

Whether your business is concerned with marketing your products within Europe, Canada, the United States or many other countries, you will find TÜV has the expertise, professionals and accreditations needed to achieve rapid market entry. TÜV provides medical services in the following areas:

• Canadian QMS requirements
• Electrical safety
• EMC services
• European directives (MDD, AIMDD & IVDD)
• FDA 510(k) reviews
• FDA third-party inspections
• Healthcare certification - important links
• Japanese Pharmaceutical Affairs Law (PAL)
• Management systems certification (ISO 13485)
• Orthopedics and sports equipment
• Training webinars

Our Medical Health Services unit is the premier notified body for medical devices globally, including the EU Medical Devices Directive, Active Implantable Medical Devices Directive and In Vitro Diagnostic Directive.

TÜV SÜD also provides FDA related services, including third-party inspections and 510(k) services, and is an SCC qualified ISO 13485 registrar for the Canadian Medical Devices Regulations, EMC testing service provider (6060112), NRTL services, Japanese approvals, and more.

EMC and environmental testing

Our EMC services unit is a leading provider of EMC testing solutions in the military and aerospace fields. Services include testing to MILSTD461, RTCA/DO160, EUROCAE/ED14E, DefStan 5941, multiple-burst and multiple-stroke lightning and HIRF testing up to 9,500V/m.

Our environmental testing unit provides dynamics (vibration and shock), acoustic, climatic and fluid dynamics testing from our accredited, state-of-the-art labs, simulating the most hostile environments.

Management service division

TÜV SÜD is an accredited Management Systems Registrar in the US, Europe and Asia, providing ISO 9001, ISO 14001, ISO/TS 16949,AS9100, ISO 13485, TL 9000, OHSAS 18001, SQF, ISO 22000, ESD S20.20 and supplier auditing services.

Industry service division

TÜV SÜD provides a variety of global conformity assessment services for industrial markets, including consulting, third-party inspection, material testing, inspection and certification, design reviews, pressure equipment testing services, type approvals and notified body services for pressure equipment manufacturers and materials producers seeking to export products to the European Community.