Online Seminar 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 Details
Session 1: Design Control
Length: 60 minutes
The FDA has determined, through analysis of product recall data, that the majority of recalls were due to a faulty design process, not faulty manufacturing. These recalled products were tested before release and later failed in unanticipated ways that were not considered in the design and testing process. According to the FDA, the factors resulting in the design process that will reduce the chances of an unsafe product include: a well-controlled design process with risk analysis, change control, design reviews, human factors analysis, hardware/software validation and feedback of the risk analysis results into the design process.
This session will answer the important and confusing question of when design control begins in a development process. The session will explain the difference between pre-release and post-release change control. Edwin will further explain the design history file and will discuss a contents checklist. He will also explain the interrelationship between ongoing risk analysis and the design process.
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
Session Highlights:
Explanation of confusing terms
Step-by-step explanation of hazard analysis process using a template
Integration of human factors studies into the hazard analysis
How to deal with residual risk?
How to integrate human factors studies into the hazard analysis
How to integrate hazard analysis into the design programWho 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.