[September 24, 2018] |
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Two Day Medical Device Software Course: Complying with the MDR & FDA Regulations 2018 (London, United Kingdom - November 20-21, 2018) - ResearchAndMarkets.com
The "Medical
Device Software: Complying with the MDR & FDA Regulations 2018"
conference has been added to ResearchAndMarkets.com's
offering.
This course will provide a comprehensive introduction to 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. You will learn how to prepare compliant
technical files and 510(k)s for medical device software products and get
insight into state-of-the-art standards and FDA guidance applicable to
software.
Day two of the course goes more in depth. It provides for a thorough
understanding on the practical implementation of the standards and
guidance applicable to software. Practical experience is shared and
common pitfalls identified for establishing and maintaining compliant
processes for design control, risk management, usability engineering,
verification and validation and clinical evaluations for software.
BENEFITS OF ATTENDING:
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Learn how to qualify and classify software in Europe and the rest of
the world
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Get in-depth understanding of the interpretations of MDR
Classification Rule 10, 11, 12, 13, 15 and 22
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Understand the implications of the MDR and US Code of Federal
Regulations for software
Gain regulatory guidance on mobile apps, software as a service, cloud
computing, artificial intelligence and continuous learning software
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Learn how to write 510K and Technical Files
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Get a practical understanding of quality management, design control
and how it applies to agile software development
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Hear the best practices on cyber security, risk management, usability
and validation
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Learn the principles of clinical evaluations for software as a medical
device
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Gain an insight into state-of-the-art standards applicable to software
Who Should Attend:
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Senior management and project leaders
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Software product managers, researchers, developers and clinical experts
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Software development process managers
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IT managers and integrators
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Internal and external auditors and/or consultants
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Regulatory affairs professionals
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Quality system and quality assurance personnel
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Technical and medical writers
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GUI designers
Agenda:
Day One
Laws and regulations A software perspective
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Introduction to the regulations
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Medical device software qualification and classification
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Software classification - EU
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Software classification case studies - EU
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Classification according to the FDA
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Bringing medical device software on the EU market
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Notified Bodies and the evidence they consider
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Practical construction of a technical file
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EUDAMED registration and distribution chain responsibilities
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On the market
End of day one
Day two
Laws and regulations - A software perspective continued from day one
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Bringing medical software on the US market
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Rest of the World (Brazil, Canada etc.)
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Standards and their implementation - A software perspective
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Standards
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Fundamental principles design control
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Design activities in detail
End of course
View source version on businesswire.com: https://www.businesswire.com/news/home/20180924005521/en/
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