The course covers the requirements of the Medical Device Regulatory Standard ISO 13485 and the regulatory framework and documentation required to market a medical device.Those attending will get an understanding of the requirements and documentation required to market and maintain compliance for medical devices in the market place. There are tutorials on the Directives, the regulatory system, the marketing of a device and the ISO 13485 Medical Device Standard. Added to this there is an introduction to risk management and the vigilance system. The course is interactive with many practical exercises and discussions.
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