Tecno-med Ingenieros has been granted ISO 13485:2016 certification for clinical and regulatory consultancy services, and for implementing and maintaining management systems for quality, training and services associated with the healthcare products industry. The assessment and certification body was SGS.

“We're very happy to be the first consultancy with this specific certification for medical devices in Spain,” says Xavier Canals, director of Tecno-med Ingenieros, on the company's 25th anniversary.

ISO 13485, derived from ISO 9000, was created to support manufacturers and distributors of healthcare products in designing quality management systems that establish and maintain the efficacy of their processes.

Tecno-med Ingenieros, a CataloniaBio & HealthTech member, is based in Barcelona and has a team of 15 engineers and specialists in regulatory affairs and quality systems.