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.
ISO 13485:2016 – Medical Device QMS
It ensures compliance with international standards for quality management in medical devices.
MDR Implementation Training Course
It certifies expertise in implementing and complying with EU MDR requirements.
CMC
Supports compliance and acts as the EU legal representative for marketed products.