Overview:
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.
Handouts
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.