2023 - Medical Device Software Validation Meeting FDA Regulations

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 in validation. How software requirements are used in validation will be described.
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. These requirements were developed after analysis by the FDA of many recalled medical devices. In this webinar, you will learn the testing 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.
LEARNING OBJECTIVES
Software Validation more than Testing
Requirements Traceability
Risk Analysis
Unit, Integration, and System Testing
Algorithm Validation
Challenges to the Software
Configuration Management
How to validate medical device software in compliance with FDA objectives
WHO WILL BENEFIT?
Engineering Personnel
Software Developers
QA
Management
SPEAKER PROFILE
Edwin Waldbusser is a consultant who retired from the industry after 20 years in the management of the development of medical devices (5 patents). He has been consulting in the areas of design control, risk analysis, and software validation for the past 8 years. Mr. Waldbusser has a BS in Mechanical Engineering and an MBA. He is a Lloyds of London certified ISO 9000 Lead Auditor and a member of the Thomson Reuters Expert Witness network.