MDR certification of a medical device verifies that the device meets all of the regulatory requirements for European Union medical devices; the certification is indicated by a CE Mark.
In order for medical devices to be certified, your company must implement a Quality Management System (QMS). Many companies use ISO 13485 as a way to implement this QMS, as this is the only QMS standard on the EU harmonized lists, and therefore it is the best way to implement the QMS as it relates to the MDR EU regulation.
Jinhua Huacheng Medical Appliance Co.,Ltd.
Manufactuer of disposable medical products: Electrosurgical pencil,grounding plate,skin stapler and ECG electrode
