Implementation, documentation and maintenance of Quality Management Systems focused on complying with NOM 241 SSA1 2012 “Good manufacturing practices for establishments that produce medical devices” (Mexico), which applies for any facility that manufactures, imports or distribute medical devices.

If you’re interested in entering markets abroad, we can assist you to obtain the ISO13485:2016 Certification “Medical Devices – Quality Management Systems – Requirements for regulatory purposes”, international regulation recognized in several countries and a mandatory requirement to distribute medical devices.

If your company specializes in the distribution and retail of medical devices we can support you in the implementation and maintenance of you Quality Management System.

We can also train your personnel in Quality Management Systems.