2-Day Course: Medical Device Software - Complying with the 2018 MDR & FDA Regulations (London, United Kingdom - April 29-30, 2019) - ResearchAndMarkets.com
DUBLIN--(BUSINESS WIRE)--Feb 22, 2019--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. Software recalls, the use of apps in medical devices, the implications of the new draft usability standard and advice on how to validate your system design will also be covered.
Benefits of Attending
Who Should Attend?
Programme Day One
Medical device software qualification and classification
Software classification - 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
Programme Day Two
Bringing medical software on the US market
Rest of the world (Brazil, Canada etc.)
Standards and their implementation - a software perspective
Fundamental principles design control
Design activities in detail
For more information about this conference visit https://www.researchandmarkets.com/research/grlw5j/2day_course?w=4
View source version on businesswire.com:https://www.businesswire.com/news/home/20190222005314/en/
Laura Wood, Senior Press 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
KEYWORD: UNITED KINGDOM EUROPE
INDUSTRY KEYWORD: TECHNOLOGY SOFTWARE HEALTH MEDICAL DEVICES
SOURCE: Research and Markets
Copyright Business Wire 2019.
PUB: 02/22/2019 10:05 AM/DISC: 02/22/2019 10:05 AM