• Medical Device Software Verification and Validation Following FDA 2023 Guidance and ISO 62304
  • Medical Device Software Verification and Validation Following FDA 2023 Guidance and ISO 62304

    • Speaker : Edwin Waldbusser
    • Session Code : ERMAY2824
    • Date : 28th May 2024
    • Time : This Event is Over and the Recorded Content is Available
    • Duration : 60 Mins



In the fast-evolving field of medical technology, ensuring the safety and efficacy of medical devices containing software is paramount. This comprehensive course delves into the critical process of software validation for medical devices, a key requirement for FDA approval. Participants will learn how to implement a robust software validation program that not only meets FDA standards but also guarantees the production of a safe and reliable product.


Key to this process is the understanding and application of risk analysis. The webinar will cover the role of risk analysis in validation and demonstrate how to leverage the international standard ISO 62304 to determine risk levels. Attendees will gain insights into how software requirements are crucial in the validation process and how they intertwine with risk-based testing strategies.


Further, the session will explore the extent of documentation required based on the risk assessment, adhering to the latest 2023 FDA Guidance on software validation. This includes a discussion on various types of testing such as unit, integration, system, and algorithm testing, as well as the challenges related to software configuration management.


Key Topics Covered:


  • Software Validation Beyond Testing
  • Requirements traceability
  • Risk analysis
  • Unit, integration and system testing
  • Algorithm validation
  • Challenges to the software
  • Configuration management


Why You Should Attend


This webinar is essential for professionals involved in the development and validation of medical device software. With the FDA's stringent requirements, understanding the depth of analysis and breadth of tests required is crucial.


This webinar will provide you with the knowledge to conduct risk-based testing effectively, produce a validated software product, and prepare the necessary documentation for FDA submission. All teachings are backed by real-world examples stemming from FDA analyses of recalled medical devices.




Participants will receive essential tools to aid in the validation process, including:


  • Software Traceability Matrix Form
  • Validation Plan Template
  • Validation Report Form


Who Will Benefit


This webinar is designed for professionals involved in the design, development, testing, and approval of medical devices with embedded software, particularly those who need to meet FDA regulatory requirements. It will be beneficial for:


  • Medical Device Engineers
  • Quality Assurance Specialists
  • Regulatory Affairs Professionals
  • Software Developers
  • Project Managers
  • Risk Management Specialists
  • Compliance Officers
  • Consultants and Advisors in Medical Device Industry

Edwin Waldbusser is a consultant retired from industry after 20 years in management of development of medical devices (5 patents). He has been consulting in the US and internationally in the areas of design control, risk analysis and software validation for the past 11 years.

Mr. Waldbusser has a BS in Mechanical Engineering and an MBA. He is a Lloyds of London certified ISO 9000 Lead Auditor and a member of the Thomson Reuters Expert Witness network.

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Tags: FDA compliance software validation medical device software risk analysis ISO 62304 quality assurance regulatory affairs software testing medical device webinar FDA documentation Edwin Waldbusser May 2024