Conducting an Effective Software Validation of Medical Device to Meet FDA Requirements

This course will teach how to conduct a software validation program that will satisfy FDA requirements and produce a safe product. We will explain the role of risk analysis in validation. How software requirements are used in validation will be described. This course is not a programming course. We will discuss what must be done but will not discuss methods to execute necessary testing.

Testing software to prove that it works and has no bugs is not sufficient to obtain FDA approval. There are additional requirements, analyses and tests that FDA feels are necessary to prevent user injuries. These requirements were developed after analysis by the FDA of many recalled medical devices. In this webinar you will learn the requirements in addition to functional tests that are required to produce a validated software product.

Areas Covered in the Session :

• Software validation more than testing
• Requirements traceability
• Risk analysis
• Unit, integration and system testing
• Algorithm validation
• Challenges to the software
• Configuration management/ design control

Who Should Attend:

• Software Developers
• Software Engineers
• IT Personnel
• Device Development Managers
• Systems engineers responsible for developing requirements
• Test Engineers
• Quality System auditors
• Engineering managers and personnel

Course Director: Edwin Waldbusser

Edwin Waldbusser retired from industry after 30 years in management of development of medical device products and development of company Quality Systems. He was involved in the development of products such as IVD devices, kidney dialysis systems and inhalation devices. His QS experience includes, design control, risk analysis, CAPA, software validation, supplier qualification/ control and manufacturing/non-conforming product programs. He now consults in the area of quality systems for medical devices with emphasis on design control, software validation, risk analysis and human factors analysis. 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.