ISO 13485: 2016
Quality management system standard for the design, production, and distribution of medical devices.
Medical Sterilisation Standard
Standard for sterilization of medical devices using ethylene oxide.
Directive 93/42/EEC
EU directive outlining essential requirements for the safety and performance of medical devices.
CMC
Supports compliance and acts as the EU legal representative for marketed products.
ISO 14001: 2015
International standard for establishing effective environmental management systems.
ISO/IEC 27001:2022
A global standard for managing and protecting information security within organizations.