Advice and support in certification of medical devices

Advice and support in certification of medical devices

p_and_s

This brand is in charge of researching and advising on quality management processes that indicate compliance with required international standards such as ISO 13485, ensuring that its products are manufactured under a strong quality control and risk management policy.

 

add0

 

Safety, risk management and quality control are issues on which our assessment center is fully trained, thinking of all the possible scenarios through software verification, medical device testing and regulatory processes.

Our engineers have experience working with physicians, startups, medical device companies and providing solutions for companies trying to get their devices to market by browsing through the approval processes of the FDA and the EU, the most sought worldwide. 

 

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