Medical Device Quality Management System
Effective Quality Management System (QMS) is vital for any medical device organization, to manufacture and deliver the devices consistently with the same quality. To challenge the global competition, the manufacturer should have integrated QMS system in the organization. This will help them to secure approvals from different regulatory authorities in quick time. We will support you to establish your QMS as per the Fifth Schedule of India MDR, ISO 13485 and 21 CFR 820.
The quality management system requirements specified in the MDR are in addition to complementary to technical requirements for products. The QMS audit of Class A & Class B medical devices carried out by the registered Notified Body, registered under rule 13 of India MDR as a body competent to carry out the audit of manufacturing site, assessment, and verification of specified category of medical devices for establishing conformity with standards.
For Class C & Class D medical devices, an inspection of the manufacturing site carried out, under rule 23, by a team of Medical Device Officers from the Central Licensing Authority. In some cases, the Central Licensing Authority may avail the services of a Notified Body for inspecting the manufacturing site of Class C and Class D medical devices.
Classification of Medical Devices in India
Medical Devices in India are classified based on risks on usage on humans to deliver its intended use.
- Low Risk Devices under Class A: ISO 13485 Mandatory
- Low Moderate Risk under Class B: ISO 13485 Mandatory
- Moderate to High Risk devices under Class C: ISO 13485 Mandatory
- High risk devices under Class D: ISO 13485 Mandatory
Notified Medical Devices