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Medical Device Software: Complying with the MDR & FDA Regulations (London, United Kingdom - November 28-29, 2017) - Research and MarketsThe "Medical Device Software: Complying with the MDR & FDA Regulations" conference has been added to Research and Markets' offering. A practical approach from Notified Body and Industry Experts This course will provide a comprehensive introduction to the regulations and requirements that apply to Medical Device Software. The seminar will be highly interactive, using real life examples and state-of- the-art practices identified from Notified Bodies in Europe. How to prepare compliant MDD Technical File documentation will be explained for Medical Device Software products. Software specification, risk management, architectures, usability and resulting design documentation will be discussed. In addition, practical tips on how to streamline the development process, understand the regulatory requirements and how Notified Bodies review Technical Files will be covered. Day two of the course will go into more depth and will focus on practical implication of Risk Management and usability, and will look in detail at the FDA guidanceon Medical Device Software compared with the MDD guidance. Software recalls will be discussed, the use of apps in medical devices as well as the implications of the new draft Usability Standard. Practical advice on how to validate your system design will also be addressed. Why you should attend
Who Should Attend:
For more information about this conference visit https://www.researchandmarkets.com/research/gh4xbg/medical_device
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