Verification, Validation and Compliance for Medical Device Software

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

Course Director: NANCY KNETTELL

Nancy Knettell, Founder and Principal at Software510K, LLC, has over 30 years in combined mechanical design, software development, and systems engineering experience primarily in the medical device industry as a Software Verification, Validation/Systems Engineer. Along with her senior level management experience with cross-functional program teams for major companies such as EMC and United Technologies, Nancy has also consulted to major medical companies such as Smith and Nephew, Philips Medical, CR Bard, Kollsman Medical, Applied Biosystems, Deka Research, Avedro and Hologic. But, for Nancy, involvement in medical device development is a personal issue. Having lost her father at an early age to heart disease, she now wants to work to help other people facing such life threatening events. It is her mission to advance the potential for life-saving medical devices through the use of quality based engineering systems.