RENEWAL OF THE ISO 13485 CERTIFICATE FOR MEDICAL DEVICES
Asisthos started the path of certification of European Standards in the mid 90`s, from the UNE-EN 46002 standard. After over 20 years we have certified this norm and have recertified all the instances of ISO 13485 and his successive revisions. We are proud to share that Asisthos has recently recertified its Quality Management System according to the UNE-EN ISO 13485: 2018 (EN ISO 13485:2016 & ISO 13485:2016) Sanitary Products: Management Systems Quality - Requirements for regulatory purposes.
This standard provides an effective framework to meet the comprehensive needs of a quality management system and allows manufacturers and service providers to comply with and demonstrate compliance with regulatory requirements. The certification through the Spanish Agency for Medicines and Health Products (AEMPS ESPAÑA) gives our clients an advantage in national and international markets.
The requirements of ISO 13485 are used by suppliers and other external parties that provide products or services to manufacturers of medical devices. Through the use of this standard, organizations will be able to demonstrate compliance with regulatory requirements, risk management, ensure best practices for quality and safety, improve processes, to finally provide confidence to patients and professionals.