- Speaker : Edwin Waldbusser
- Session Code : EWOCT2522
- Date : 25th October 2022
- Time : This Event is Over and the Recorded Content is Available
- Duration : 75 Mins
Medical Device Software Validation Meeting FDA Regulations
Overview:
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 for Participants - software traceability matrix form, validation plan template, and validation
report form
By
attending this webinar participants will learn:
- Software
validation is more than testing
- Requirements
traceability
- Risk
analysis
- Unit,
integration and system testing
- Algorithm
validation
- Challenges
to the software
- Configuration
management
Why
should you attend?
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.
Who
will benefit?
- Engineering
personnel
- Software
developers
- QA
- Management
Edwin
Waldbusser is a consultant retired from industry after 20 years in management
of development of medical devices (5 patents). He has been consulting in the US
and internationally in the areas of design control, risk analysis and software
validation for the past 11 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.
Enrollment Options
Tags: Medical Device, Software Validation, FDA Regulations, Edwin, Waldbusser, October 2022, Webinar