Medical Device Software: Complying with the MDR & FDA Regulations 2018 - Two Day Course - London, United Kingdom - November 20th-21st, 2018

News provided by

Sep 24, 2018, 10:30 ET

DUBLIN, Sept 24, 2018 /PRNewswire/ --

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 validationand clinical evaluations for software.

BENEFITS OF ATTENDING:

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 n 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

Agenda:

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/7b8vs6/medical_device?w=5

Media Contact:

Research and Markets
Laura Wood, Senior Manager
[email protected]

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

U.S. Fax: 646-607-1907
Fax (outside U.S.): +353-1-481-1716

SOURCE Research and Markets