How software requirements are used in validation

Fremont, CA
Software Validation, Quality assurance, Risk analysis, Regulatory Affairs Courses Online, development of medical devices, latest software updations

This course is NOT a programming course. We will discuss what must 

be done but will not discuss methods to execute necessary testing.

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 requirements,analyses and 

tests that FDA feels are necessary to prevent user injuries.

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

Who Will Benefit:
Engineer Management
Software Engineer
Quality Assurance

Speaker Profile:
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 8 years.

Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407

Schedule of Presentations:

Tuesday, January 30, 2018
3D Tissue Models
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