Medical Device Software Validation that Meets FDA Requirements
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.Learning ObjectivesSoftware validation is more than testingRequirements traceabilityRisk analysisUnit, integration and system testingAlgorithm validationChallenges to the softwareConfiguration managementCourse Level - Basic to IntermediateWho Should AttendEngineering personnelSoftware developersQAManagement Why Should You AttendTesting 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.
Single
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.
Learning Objectives
- 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
- QA
- Management
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.