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Visit us at RAPS 2017!

We look forward to meeting you at the 2017 RAPS Regulatory Conference.

 

Visit us at 2017 RAPS Convergence & meet with TUV USA's Medical Division Director, Bradley Chen and other members of TUV USA. Discover what TUV USA has to offer for certifications to the medical devices community:

  • CAN CSA ISO 13485
  • ISO 13485 under CMDCAS
  • ISO 13485 under MDSAP 
  • Medical Device Directive/Regulation Active Implantable MDD

Please visit our Medical Division pages for more information.

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ISO 13485 Certificate

ISO 13485: 2003 represents the requirements that medical device manufacturers must incorporate into their management systems
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MDSAP Program

The objective of the MDSAP is to achieve a common audit standard which takes the different regulatory requirements of national approval bodies into consideration.
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Medical Devices Directive (MDD)

Medical device" means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, together with any accessories, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings...
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