DUBLIN–(BUSINESS WIRE)–The “Medical
Device Software: Complying with the MDR & FDA Regulations 2018”
conference has been added to ResearchAndMarkets.com’s
offering.
This course provides a comprehensive appraisal of the regulations and
requirements that apply to medical device software worldwide.
The seminar will be highly interactive, using real-life examples and
state-of-the-art practices identified by Notified Bodies in Europe.
There will be in-depth coverage on how to prepare compliant technical
file documentation for medical device software products and a review of
software specification, risk management, architectures, usability and
resulting design documentation. In addition, there will be practical
tips on how to streamline the development process, understand the
regulatory requirements and how Notified Bodies review technical files.
There will be sessions on the practical implication of risk management
and usability and an analysis of the differences between FDA guidance
and MDR guidance on medical device software….
