Quality Management
In the CREATE MEDIC Group, ISO 13485:2016 (Global Quality Management Standard for Medical Devices) is certified by SGS UK Ltd. and CE marking of Medical Devices Directive 93/42/EEC is certified by SGS Belgium.
Moreover, CE marking of Medical Devices Regulation 2017/745/ is certified by TÜV SÜD Product Service GmbH.
We also comply with the Pharmaceuticals and Medical Device Act and applicable laws and regulations in the P.R. China, South Korea, Taiwan, South American and Middle East countries.
- Quality policy
- Continuing provision of quality innovation for realization of products trusted and supported by customers.
- DALIAN CREATE
- VIETNAM CREATE
※Click to enlarge
CE Certificate for Class I, IIa, IIb
(DALIAN CREATE)
ISO 13485 Certificate
(DALIAN CREATE)
ISO 13485 Certificate
(VIETNAM CREATE)
ISO 13485 Certificate
(CREATE MEDIC)
CE Certificate for
Class IIa, IIb
(CREATE MEDIC)
MDR Certificate for Class IIa
(CREATE MEDIC)