(ISO 13485 -2003 Medical Devices )specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.
A medical device is “an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent.
Companies that are involved in the production and distribution of medical devices intended for commercial distribution in the United States (U.S.) are required to register annually with the FDA. Most establishments that are required to register are also required to list the devices and the activities performed on those devices at that establishment.
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– ISO 13485
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– 21 cfr part 820 (Medical Devices) Quality System Regulation
– 510(k) is a premarket submission US
– CE Marking Gain market access in Europe