ISO 13485 - Medical Devices Quality Management System (MDQMS)
Quality Management System
A medical device can by anything which is related to healthcare but doesn't have pharmaceutical action. Medical devices range from simple thermometer to complex programmable machines (microchip technology, laser surgical devices etc).
The FDA defines a medical device as:
"an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:
- recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,
- intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
- intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes.
ISO 13485 / Medical Devices Quality Management System Standard (MDQMS) is an effective Quality Management System derived from globally accepted ISO 9000 series. This standard adopts ISO 9000 process-based modal for medical device manufacturing environment
ISO 13485 / MDQMS is a regulatory standard whose focus is meeting customer requirements, including regulatory requirements, and maintaining the effectiveness of the QMS. This differs from ISO 9001:2000 which focuses on customer satisfaction and continual improvement.
Benefits of ISO 13485 / Medical Devices Quality Management System (MDQMS)
- Increase customer confidence
- Meet customer expectations
- Promotes better communication
- Increase efficiency
- Improves supplier relationships
- Increases speed to market
- Demonstrate that you provide safer medical devices
