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Conference

Medical Device Software: Complying with the MDR & FDA Regulations

20 - 21 Nov 2019 Add To Calendar
DoubleTree by Hilton Hotel London - West End, London, UK

About Users 19 Reviews Exhibitors Photos Speakers 14 Travel Deals

PLEASE NOTE: Due to popular demand this event is now running as a 3-day event.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 .. continue reading 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.

Highlights

  • 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 Rules 10, 11, 12, 13, 15

Timings

9:30 AM - 5:00 PM (General)

Entry Fees

Paid Ticket Starts from 1849 GBP View Details

Participants

100 - 500
Delegates

10 - 50 Exhibitors Estimated Count

Category & Type

Conference
Medical & Pharma
Education & Training

Editions

20 - 21 Nov 2019 Interested
29 - 30 Apr 2019
20 - 21 Nov 2018
23 - 24 May 2018
View More

Frequency Bi-annual

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Management Forum Ltd UK

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User Community [ Users who have shown interest for this Event ]

Judith Makondo

Judith Makondo

Marketing at Pharmacy

Harare, Zimbabwe
Louise

Louise

Operations Manager at Uovo technologies

Chester, United Kingdom
Green Hills Software

Green Hills Software

Vice President Medical Industry Business Development at Green Hills Software

Franklin, United States
David Jobling

David Jobling

Product Lead at Apperta Foundation

Stockton-on-Tees, United Kingdom
Nicolas Romain

Nicolas Romain

International Marketing Executive at Enovacom

Marseille, France
oliver froment

oliver froment

Managing Director at Pro Capital

London, United Kingdom
Ksenia

Ksenia

Distributor at Pelvic Health

Dubai, United Arab Emirates

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Speakers (past edition)

Speaker
Mark Anderson

Mark Anderson

IP lawyer at Anderson Law LLP Oxford, United States
Speaker
Ulrich Blumenröder

Ulrich Blumenröder

Attorney at Grünecker, Kinkeldey, Stockmair & Schwanhäusser,... Munich, Germany
Speaker
Gabriella Braun

Gabriella Braun

Director, Working Well and senior organisational psychologist developing leaders, teams... London, Canada
Speaker
William Cook

William Cook

Partner at Marks & Clerk Solicitors LLP London, Canada
Speaker
NORAH LIGHTOWLER

NORAH LIGHTOWLER

partner at Lightowler Associates Darlington, United Kingdom
Speaker
Paul Tunnah

Paul Tunnah

CEO & Founder of pharmaphorum media, driving innovation in pharma.... Windsor, Canada
Speaker
Christine Bendall

Christine Bendall

Regulatory consultant : drug safety at PharView Ltd Stoke-on-Trent, United Kingdom

Visitor Ticket Price

1849 GBPDelegates
51.520093 -0.122097

Venue Map & Directions

map of DoubleTree by Hilton Hotel London - West End

DoubleTree by Hilton Hotel London - West End

92 Southampton Row, Bloomsbury, London WC1B 4BH
UK

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