ISO 13485: 2016
Quality management system standard for the design, production, and distribution of medical devices.
Directive 93/42/EEC
Standard for sterilization of medical devices using ethylene oxide.
CMC
It Supports compliance and acts as the EU legal representative for marketed products inside Europe.
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.
CFDA-医疗器械注册证
The official registration certificate required for medical devices sold in China.
ISO 14001: 2015
International standard for establishing effective environmental management systems.
ISO 27001: 2015
A global standard for managing and protecting information security within organizations.