Medical Devices

Medical devices are now common in everyday life. The advancement of technology has brought us closer to devices that help in the diagnosis as well as the mitigation or cure of diseases. Today even our phone and watches are being used as medical devices. We have a long way to see how technology and software effects the development and the intended use of medical devices. Ultimately, we need to ensure safety and quality of all devices used in patient care.

Industry professionals working as Contract Manufacturer or Sterilizer, foreign exporter, initial distributor, manufacturer, re-packager, re-labeler, re-processor of single use devices and specification developer all need to comply to the established regulatory proceedings of the Food and Drug Administration (FDA) in order to protect the user against the risk associated with the design, manufacture and packaging of medical devices. Webinar Compliance has been the front runner when it comes to training programs on medical devices. We regularly discuss and present courses on Medical device Classification, 510k submissions, Premarket Approval (PMA), Software as a Medical Device (SaMD), IVD’s (In Virtro Diagnostics) and cGMP (Current Good Manufacturing Practices). These medical devices training programs and medical device webinars would be essential to ensure that the specifications for the devices and manufacturing process are adequate and safe to produce. The ultimate goal of our medical device courses is to ensure industry professionals stay compliant as per the latest guidance issued by the FDA, EMA, WHO and other notified bodies.