Software design is a complex set of interactions within the device, with the connecting devices, and with users of the device. Usually multiple factors affect the device performance. Therefore right validation is the key to prevent device recalls. The software associated with medical devices is getting closer scrutiny than ever before because of increasing prevalence in industry, greater chance for problems, and the comfort level of FDA investigators in asking for and auditing software applications.
This webinar will teach you how to design, build and test medical device software in preparation for the successful 510k submissions. It will cover medical device software user requirements, software architecture, design, unit testing and more.
Why You Should Attend:
This webinar is essential for medical device companies interested in submitting software enabled medical devices or software as a medical device to the FDA for 510K approval. One of the biggest risks most company’s face when submitting their device for approval is finding out after seven or more months of waiting that the 510K has been denied because the software portion of the submittal is inadequate and not compliant.
This webinar will ensure that device companies will know exactly what documentation needs to be prepared so the software portion of the submittal will be in compliance preventing delays of the 510K approval.
Companies can also face potential audit risks and serious findings post submittal that can block their ability to ultimately sell their product successfully. This course will ensure that you know what is expected to have in place for compliance for your company during the preparation of a 510K to prevent this risk.
Objectives of the Presentation:
FDA Quality System Requirements for software
FDA guidelines on software verification and validation
Smart software verification methods
How to design smart validation tests
How to conduct black box testing and white box testing to perform thorough validation
How to conduct diabolic tests and wicked tests to avoid product recalls
Areas Covered in the Session :
Introduction to 62304
Level of concern
High level risk management
Medical device software user requirements
Medical software device system requirements
Medical device software V Model
Software requirements
Software architecture
Software design
SOUP
Unit testing
Integration testing
Who Should Attend:
Software developers and managers
Internal auditors
Quality Assurance personnel and management
Software quality personnel
Software test personnel
Regulatory affairs personnel and management
IT managers and system administrators
Software validation engineers