Verification and validation of medical devices

Verification and validation of medical devices

Testing is a critical step in the transformation process of innovative design in a reliable and marketable product. Thus it has been created solutions for technology assessment. Tests to help you demonstrate your device is compliant with the regulations anywhere in the world. 

 

verif0  ver2

 

Our center offers different methods non-destructive quality control testing, as well as physical tests, check and rehearse medical devices in accordance with national and international requirements and standards.

 

The testing covers prototype and production cycle and evaluate the devices to have the quality of any product with the CE mark by laboratory testing for electrical safety, electromagnetic compatibility in addition to software, mechanical and functional testing.

 

  • IEC 60601 (Complete series)
  • ISO 14971
  • EMC Testing
  • Functional safety
  • Environmental Testing

Leaders

  • Ing. MSc. Javier Hernando García Ramos. 
  • Ing. MBA Juan Guillermo Barreneche Ospina.

 

Associated Researchers

  • Ing. MSc (c) Juan Camilo Guerrero Valencia.
  • Ing. Mónica Yaneth Ruiz López