Medical Device Software Validation that Meets FDA Requirements
Ed retired from industry after 27 years in management of development of medical device products and development of company Quality Systems. He has been a consultant for the last10 years, working with companies from startups to Fortune 100 in the US, Germany, United Kingdom, Netherlands, Canada, Poland, and Saudi Arabia. He specializes in design control, risk analysis, human factors, software validation, cybersecurity and supplier qualification/ control. Ed has a B.S. Mechanical Engineering from NYU and a M.B.A from Drexel University. He is certified by Lloyds of London as an ISO 9000 Lead Auditor and is a member of the Thomson Reuters Expert Witness network. He has 5 issued patents.
This course will teach how to conduct a software validation program for medical devices containing software that will satisfy FDA requirements and produce a safe product. We will explain the role of risk analysis invalidation. How software requirements are developed and used in validation will be described.
- Software validation is more than testing
- Requirements traceability
- Risk analysis
- Unit, integration and system testing
- Algorithm validation
- Challenges to the software
- Configuration management
Course Level - Basic to Intermediate
Who Should Attend
- Engineering personnel
- Software developers
Why Should You Attend
Testing software to prove that it works and has no bugs is not sufficient to obtain FDA approval. There are additional analyses and tests that FDA feels are necessary to prevent user injuries. Also required are good Design control and Configuration Management. These requirements were developed after analysis by the FDA of many recalled medical devices In this webinar, you will learn how to meet FDA requirements and the analysis that is required in addition to functional tests to produce a validated software product. Handouts are software traceability matrix form, validation plan template, and validation report form.