Two Day Medical Device Software Course: Complying with the MDR & FDA Regulations 2018 (London, United Kingdom - November 20-21, 2018) - ResearchAndMarkets.com

September 24, 2018

DUBLIN--(BUSINESS WIRE)--Sep 24, 2018--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.


Learn how to qualify and classify software in Europe and the rest of the world Get in-depth understanding of the interpretations of MDR Classification Rule 10, 11, 12, 13, 15 and 22 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 Learn how to write 510K and Technical Files Get a practical understanding of quality management, design control and how it applies to agile software development Hear the best practices on cyber security, risk management, usability and validation Learn the principles of clinical evaluations for software as a medical device Gain an insight into state-of-the-art standards applicable to software

Who Should Attend:

Senior management and project leaders Software product managers, researchers, developers and clinical experts Software development process managers IT managers and integrators Internal and external auditors and/or consultants Regulatory affairs professionals Quality system and quality assurance personnel Technical and medical writers GUI designers


Day One

Laws and regulations A software perspective

Introduction to the regulations Medical device software qualification and classification Software classification - EU Software classification case studies - EU Classification according to the FDA Bringing medical device software on the EU market Notified Bodies and the evidence they consider Practical construction of a technical file EUDAMED registration and distribution chain responsibilities On the market

End of day one

Day two

Laws and regulations - A software perspective continued from day one

Bringing medical software on the US market Rest of the World (Brazil, Canada etc.) Standards and their implementation - A software perspective Standards Fundamental principles design control Design activities in detail

End of course

For more information about this conference visit https://www.researchandmarkets.com/research/dzpvgn/two_day_medical?w=4

View source version on businesswire.com:https://www.businesswire.com/news/home/20180924005521/en/

CONTACT: ResearchAndMarkets.com

Laura Wood, Senior Manager


For E.S.T Office Hours Call 1-917-300-0470

For U.S./CAN Toll Free Call 1-800-526-8630

For GMT Office Hours Call +353-1-416-8900

Related Topics:Medical Devices



SOURCE: Research and Markets

Copyright Business Wire 2018.

PUB: 09/24/2018 08:44 AM/DISC: 09/24/2018 08:44 AM


Update hourly