ISO 13485:2016 Medical Devices Quality Management System
What is ISO 13485:2016 Medical Devices Quality Management System
Clinical device quality administration framework (QMS) is an organized arrangement of methodologies and cycles that cover all aspects of configuration, fabricating, provider executives, risk the board, objection taking care of, clinical information, stockpiling, conveyance, item marking, and so on.
Most clinical devices will necessitate some form of QMS; the complexity of the QMS will vary depending on the device’s characterization. For example, organizations producing medium-hazard (Class II) or high-hazard (Class III) devices will require a different QMS implementation than organizations producing generally safe, non-clean, non-estimating, non-reusable careful instrument devices (Class I).