3 Hrs Design Control Virtual Boot camp: Hazard and Usability Analysis

01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 180 Minutes

Edwin Waldbusser is a consultant who is retired from industry after 20 years in management of development of medical devices (including five patents)


How to comply with the FDA’s requirements for designing and testing a medical device


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

Areas Covered

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-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.

Many new concepts have been introduced. This session will explain these new concepts and will provide you with examples so that the process is clear. One of the techniques described in ISO 14971 is hazard analysis, which is the most powerful of the risk management techniques because it considers risks in normal operation as well as fault conditions. FMEA and FTA consider only fault conditions and are more suited as reliability tools than as product safety tools. 

In this session, Edwin will explain in detail the process of conducting a hazard analysis. It will explain confusing terms like “hazard,” hazardous situation,” “harm,” “causative event,” “ALARP,” “risk index” and “residual risk.” 

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 program

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.

Human factors/usability is the analysis of how people interact with medical devices. This session will explain the process of conducting rigorous human factors studies throughout the design process, integrating it with the device risk analysis and design process, and validating the effectiveness of the studies. Edwin will also discuss various types and methods of human factors analysis. This process conforms to the new ISO 62366 standard and the new FDA Guidance document. 

Session Highlights: 
•       User error vs. use error
•       Human factors studies for design process
•       Device risk analysis
•       Validation of the effectiveness of human factors studies

Who will Benefit

•       Medical Device Engineering Personnel
•       Medical device designers
•       R&D
•       QA / RA
•       Software Developers
•       Manufacturing
•       Operations
•       Mid- and Senior-level Management

Industries who can attend

This 180-minute online course is intended for professionals in the Medical Device, Biotechnology,Pharmaceutical Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel

Speaker Profile

Edwin Waldbusser

Edwin Waldbusser retired from industry after 20 years in management of development of medical device products and development of company Quality Systems. Products included IVD devices, kidney dialysis systems and inhalation devices. 

His QS experience includes design control, risk analysis, CAPA, software validation, supplier qualification/control and manufacturing/non-conforming product programs.

Ed has a B.S. Mechanical Engineering from NYU and a M.B.A from Drexel University. He is certified by Lloyds of London as an ISO 9000 Lead Auditor and is a member of the Thomson Reuters Expert Witness network. He has 5 issued patents.

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