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Event Details


Medical Device Software: Complying with the MDR & FDA Regulations

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Who should attend?

Senior Management, Project Leaders Internal / External Auditors and/or Consultants Regulatory Affairs Quality Systems and Quality Assurance Personnel IT Managers New Product Development, Marketing Software Product and Process /Manufacturing Engineering Staff Document Control / User Manual Writers R&D Software Engineering Team Members and GUI Designers



This course will provide a comprehensive introduction to the regulations and requirements that apply to Medical Device Software. The seminar will be highly interactive, using real life examples and state-of- the-art practices identified from Notified Bodies in Europe. How to prepare compliant MDD Technical File documentation will be explained for Medical Device Software products.

Software specification, risk management, architectures, usability and resulting design documentation will be discussed. In addition, practical tips on how to streamline the development process, understand the regulatory requirements and how Notified Bodies review Technical Files will be covered.

Day two of the course will go into more depth and will focus on practical implication of Risk Management and usability, and will look in detail at the FDAguidance on Medical Device Software compared with the MDD guidance. Software recalls will be discussed, the use of apps in medical devices as well as the implications of the new draft Usability Standard. Practical advice on how to validate your system design will also be addressed.



  • Understand the Regulatory Framework
  • Comply with the MEDDEV on Stand Alone Software
  • Know the Principles to Bring a Medical Device Software Product to the Market
  • Review the Practical Construction of a Technical File
  • Be Aware of the US Code of Federal Regulations and its Implications for Software
  • Gain FDA Guidance on Medical Device Software Systems and Mobile Apps
  • Receive Key Information on Design Aspects of Medical Software
  • Review the IEC and EN ISO Standards and their Applicability; including Risk Management and Usability
  • Understand the Fundamental Principles of Quality Management & Design Control
  • Clarify Design Activities; including Architecture & Design, Configuration Management and Verification and Validation




Leigh White

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