- Global Pharma News & Resources
01-May-2019 - 02-May-2019

Medical Device Software: Complying with the MDR & FDA Regulations

  • Location:
    • Jermyn Street
    • London
    • Greater London
    • SW1Y 6JF
    • United Kingdom
  • View on a map

Course Overview

This course will provide a comprehensive introduction to the regulations and requirements that apply to medical device software wordwide. 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 validation
and clinical evaluations for software. 

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 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