Medical devices range from simple tongue depressors and bedpans to complex programmable pacemakers with micro-chip technology and laser surgical devices. In addition, medical devices include in vitro diagnostic products, such as general purpose lab equipment, reagents, and test kits, which may include monoclonal antibody technology. Certain electronic radiation emitting products with medical application and claims meet the definition of medical device. Examples include diagnostic ultrasound products, x-ray machines and medical lasers.
Devices when labeled, promoted or used in a manner that meets the definition in section 201(h) of the Federal Food Drug & Cosmetic (FD&C) Act will be regulated by the Food and Drug Administration (FDA) as a medical device and is subject to premarketing and post marketing regulatory controls.
At compliance training panel, we aim at providing effective trainings to meet the compliance requirements. Our training services are built around knowledge, motivation and understanding of customer requirements, to make sure the CTP service experience creates true impact. ;
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