René Mendiola (MX)


  • 2018  MBA and Human Resources 

  • 2012  Black Belt Certificated  by ITESM

  • 2002 MBA 

  • 1999 Industrial and Systems Engineering by ITESM  (Campus Mexico City)

  • Leader Auditor  ISO13485:2016,  ISO27001, ISO45001, ISO14001.

  • Master Black Belt /  Lean Leader   by ITESM

  • Consultant and Trainer approved by  SE /STPS



  • More than 15 years of experience in consultancy and training in Quality Management Systems and regulatory compliance for the Medical Device and Aerospace industry.

  • Experience in QMS ISO13485, GMP, NOM 241, Validation Protocols, FDA ( CFR 820) y JPAL.

  • Companies supported: ICU Medical, Smith Medical, Medtronic, Welch Allyn, Flex, ENCAMESA, OSSUR, ONCORE, VICTORY, INTUITIVE, Avent, etc.

  • Member of Baja´s Medical Device Cluster  and MDG Consulting Group Director.