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.
SGS Extension Letter 1
It confirms SGS Belgium NV’s approval of the manufacturer’s medical device application under EU regulations.
SGS Extension Letter 2
It confirms SGS Belgium NV’s receipt and approval of the manufacturer’s medical device application per EU requirements.
CMC
Chemistry, Manufacturing, and Controls. It Supports compliance and acts as the EU legal representative for marketed products inside Europe.