4:06 Webinar recording excerpt
Review this educational virtual panel discussion of ‘How Medical Device Classification and Identification Impact the Device Life Cycle’. Speakers from Reed Tech, Greenlight Guru and GMDN Agency discuss the topic and take audience questions.
The lifecycle of a medical device can last years, even decades, encompassing everything from initial design and approval to maintenance, recalls and decommissioning. Very early in the lifecycle, it is important to start thinking about how the device will be classified and if it will differ depending on the regulatory agency.
Device classification can take many forms such as device type described by FDA Product Codes and the Global Medical Device Nomenclature (GMDN) to broader descriptions like the medical specialty, device class and whether the device is implantable or sterile.
Beyond gaining regulatory approval or clearance, understanding a device’s classification and unique identification can help with competitive intelligence, risk management, device tracking and quality management.
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