Conducting an Effective Software Validation of Medical Device to Meet FDA Requirements
Duration : 60 Minutes
Edwin Waldbusser, Medical Device
Ed 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, softwa Read more
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.
Course Objectives:
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.
Course Outline:
• Software validation more than testing
• Requirements traceability
• Risk analysis
• Unit, integration and system testing
• Algorithm validation
• Challenges to the software
• Configuration management/ design control
What You Get:
• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points
Who Will Benefit:
• Software Developers
• Software Engineers
• IT Personnel
• Device Development Managers
• Systems engineers responsible for developing requirements
• Test Engineers
• Quality System auditors
• Engineering managers and personnel
Please reach us at 1-888-844-8963 for any further assistance or if you wish to register
100% MONEY BACK GUARANTEED
Refund / Cancellation policyGet In Touch
Similar Trainings
Risk Assessment in Medical Device Design
LIVE : Scheduled on
08-January-2025 :01:00 PM EST
|
The DHF, DMR, DHR, and Technical Documents File
LIVE : Scheduled on
09-January-2025 :01:00 PM EST
|
Scrutinizing Test Method Validation (TMV) to Verify the Performance of a Medical Device
LIVE : Scheduled on
16-January-2025 :01:00 PM EST
|
