Medical Services

Achieving success in global markets requires gaining rapid market entry for your medical device products. The Medical Health Services unit of TÜV SÜD 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 SÜD America has the expertise, professionals, and accreditations needed to achieve rapid market entry. TÜV SÜD  America provides medical services in the following areas:

• Canadian QMS Requirements
• Electrical Safety
• EMC Services
• European Directives (MDD, AIMDD & IVDD) -Download Transition to EC Directive 2007/47/EC
• FDA 510(k) Reviews
• FDA Third-Party Inspections
• Healthcare Certification - Important Links
  
• IEC 60601-1:2005 3rd Edition
• Japanese Pharmaceutical Affairs Law (PAL)
• Management Systems Certification (ISO 13485)
• Orthopedics & Sports Equipment
• Training Webinars
• Public Training Seminars
  

New application forms available, click here.

For more information, contact us.