What is design control? 2019 - Design Control Virtual Bootcamp: Hazard and Usability Analysis

Overview
The U.S. Food and Drug Administration (FDA) is responsible for regulating the development of and manufacturing processes for medical devices. The FDA also determines the necessary requirements before these medical devices can hit the markets. It’s crucial that FDA design controls are strictly followed in the process of product development.
Session Objectives
What is design control?
When does it start?
Why hazard analysis following ISO14971 is the best risk control method
Human factors following new FDA guidance and ISO 62366
Why software validation is more than testing
Who Will Benefit
Medical Device Engineering Personnel
Medical device designers
R&D
QA / RA
Software Developers
Manufacturing
Operations
Mid- and Senior-level Management
CEOs and CFOs
Sales and Marketing
Purchasing
Other Medical Products Manufacturing Stakeholders
Speaker
Edwin Waldbusser is a consultant who is retired from industry after 20 years in management of development of medical devices (including five patents).