Design Control of Hazard Analysis, Human Factor Virtual Bootcamp
Design Control Virtual Bootcamp:
Hazard and Usability Analysis
Presented By: Edwin Waldbusser
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The FDA will only approve devices that are designed so that it is practically impossible for people to accidentally harm themselves even if they use the device improperly.
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.
Session-2: Hazard Analysis

Length: 60 minutes

The FDA expects that risk management will be conducted as a part of a product development program. The agency recommends using ISO 14971 as a guide and has accepted it as a recognized standard. Hazard analysis is the most powerful of the risk management tools described in ISO 14971; however, it can be very confusing.
Session-3: Human Factors/Usability Analysis

Length: 60 minutes

The FDA will only approve devices that are designed so that it is practically impossible for people to accidentally harm themselves – even if they use the device improperly. The FDA has replaced the term “user error” with “use error.” The FDA considers use error to be a device non-conformity because human factors must be considered in the design process. The burden is on the device designer to create an “idiot-proof” product.
Bonus Handouts – Get Additional Material with Each Registration

Who Should Attend?
  • 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
About Our Speaker
Dr. John RyanEdwin 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.

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