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REGULATORY AFFAIRS

Crt dispositivos médicos

We advice you throughout all the life cycle of your medical device; making it easier to obtain the registration(s) needed in the countries in which you’re interested to distribute your medical device.

 

Processes in Mexico (COFEPRIS)::

  • Operation Notices and Sanitary Responsible
  • Dossiers’ preparation for New Health Registrations (classes I, II and III)
  • Health Registrations Extensions (Renewals)
  • Health Registrations’ Technical and Administrative Modifications
  • Compliance consulting of NOM 137 SSA1 2008 – Medical Devices Labelling

Processes in Latin America, Canada and Europe:

Preparation of technical documentation to register medical devices

Consulting to comply with MDSAP audits

Preparation of technical documentation for obtaining CE mark