This content is a press release from our partner Business Wire. The AP newsroom and editorial departments were not involved in its creation.
PRESS RELEASE from provider: Business Wire
This content is a press release from our partner Business Wire. The AP newsroom and editorial departments were not involved in its creation.

2-Day Course: Medical Device Software - Complying with the 2018 MDR & FDA Regulations (London, United Kingdom - April 29-30, 2019) - ResearchAndMarkets.com

February 22, 2019

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/

CONTACT: ResearchAndMarkets.com

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



SOURCE: Research and Markets

Copyright Business Wire 2019.

PUB: 02/22/2019 10:05 AM/DISC: 02/22/2019 10:05 AM