Online Webinar 2019 - 3 Hrs Virtual Seminar 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.
However, designing a medical device and testing it to prove that it works is not sufficient in the eyes of the FDA to provide a safe product for users. Medical device designers, developers, engineers and manufacturers must be intimately familiar with the FDA’s requirements that ensure a product is safe for use before it reaches the markets.
In this Virtual Boot Camp, Edwin Waldbusser will guide you on how to comply with the FDA’s requirements for designing and testing a medical device.
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
Session Highlights:
Reasons for design control
When design control begins
Elements of a design control program
How risk managements fits into design control
How human factors fits into design control
Change control
Understanding validation consists of more than testing
Design history file
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). He has been consulting in the areas of design control, risk analysis and software validation for the past nine years. Edwin 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.