PharmiWeb.com - Global Pharma News & Resources
28-Apr-2020 - 30-Apr-2020

Medical Device Software: Complying with the MDR & FDA Regulations

  • Location:
    • Holiday Inn London - Kensington Forum
    • Cromwell Road
    • London
    • Greater London
    • SW7 4DN
    • United Kingdom
  • View on a map

Course Overview

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 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.

Why you should attend

  • 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 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 510(K) 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 andvalidation
  • 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