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Regulatory Compliance Product Managers, Project Managers, Quality Assurance, Device Design Engineers
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Seminar Summary:

The benefits of this course include the following:Show you how Human Factors can actually decrease development time and overall product development costs.Show how to plan and execute strategic Human Factors testing cycles. (see full course description)

 
 
 

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Training Course Syllabus:


Integration of Human Factors into Medical Device Design: FDA and European Commission - 2-Day In-person Seminar

Course Description:

The FDA and the European Commission have both issued several guidances and standards over the past 5 years with respect to the role of Human Factors in Medical Device design, evaluation and approval. These include:

ANSI/AAMI HE75: 2009(R) 2013
IEC 62366-1:2015
Draft Guidance for Industry and Food and Drug Administration Staff - Applying Human Factors and Usability Engineering to Optimize Medical Device Design (June 22, 2011)
Design Considerations for Devices Intended for Home Use, Guidance for Industry and Food and Drug Administration Staff (November 24, 2014)
Draft Guidance for Human Factors and Combination Products (In progress by the FDA)

Although the two organizations are coming closer and closer together on the role of Human Factors in the Medical Device industry, the implementations can be somewhat different. There are ways to leverage the implementation of Human Factors into the device design, development and validation to accommodate both approving bodies.

At the same time Medical Device companies have come to approach Human Factors as just another ‘hoop’ to go through to gain approval of their devices. In fact, they see it as a ‘barrier’ to getting a device to market quickly and inexpensively. Indeed, the way most Medical Device companies are approaching Human Factors, it does add time and cost a significant amount of money. This course will show that when implemented correctly, in fact, Human Factors can actually save time and money and therefore increase the profitability of a medical device.

The benefits of this course include the following:

Show you how Human Factors can actually decrease development time and overall product development costs.
Show how to plan and execute strategic Human Factors testing cycles.
Provide a thorough understanding of the requirements of the FDA and the European Commission (CE mark)
Provide a thorough understanding of the how Human Factors can present data for lowering use risk by design early in the design cycle.
Provide a thorough understanding of the role of user Training and associated documentation (e.g., Information for Use, Labeling, etc.
Provide a thorough understanding of the usability design file.

Learning Objectives:

You will:

Learn what encompasses Human Factors/Usability
Learn which Human Factors Standards and Regulations apply to your products
Learn how to create and implement Factors into your product development cycle
Learn the relationship between Human Factors and Risk Management
Learn how to create a Human Factors Standard Operating Procedure (SOP)
Learn what comprises a Human Factors/Usability Design History File
Learn how to define a Human Factors Testing Strategy
Learn how to define and integrating Users, User Needs and User Requirements into the Product development Life Cycle
Learn how to organize Human Factors Testing
Learn how to analyze the results of Human Factors Testing and their relationship to Risk Management

Areas Covered:

Defining Human Factors, Ergonomics, and Usability
ANSI/AAMI HE75: 2009(R) 2013
IEC 62366-1:2015
Draft Guidance for Industry and Food and Drug Administration Staff - Applying Human Factors and Usability Engineering to Optimize Medical Device Design (June 22, 2011)
Design Considerations for Devices Intended for Home Use, Guidance for Industry and Food and Drug Administration Staff (November 24, 2014)
Draft Guidance for Human Factors and Combination Products (TBD for release from the FDA)
Human Factors Formative Testing
Human Factors Summative Testing
Information for Use (IFU)/ Labelling
User Training
Creating and Maintaining a Usability History File
Using Human Factors to Design Medical Devices, not just evaluate.

Course Outline:
DAY ONE (8:30 AM – 4:30 PM)

Registration Process: 8:30 AM

8:30-8:45 Meet/Greet/Introductions

8.45 am – 10.15 am: Human Factors and Medical Devices: Setting the Stage
Definitions of Common Terms
How Human Factors Became a Requirement for the Medical Device Industry
Overview of the Medical Device Standards and Requirements for the FDA and CE Mark
10.15 am – 10.30 am: Break
10.30 am – 12.00 pm: Human Factors and Risk Management
What is an uFMEA?
The role of Human Factors and the uFMEA
The Human Factors Activities and Documents that contribute to the uFMEA
Draft Guidance for Industry and Food and Drug Administration Staff - Applying Human Factors and Usability Engineering to Optimize Medical Device Design (June 22, 2011)
12.00 pm – 1.00 pm: Lunch
1.00 pm – 2.45 pm: Human Factors and Device Design
The role of Human Factors in Device Design
The Human Factors Activities and Documents that contribute to Device Design
ANSI/AAMI HE75: 2009(R) 2013
Design Considerations for Devices Intended for Home Use, Guidance for Industry and Food and Drug Administration Staff (November 24, 2014)
2.45 pm – 3.00 pm: Break
3.00 pm - 4.30 pm: Human Factors Standard Operating Procedure (SOP)
The Usability Design File?
IEC 62366-1:2015
Creating and Integrating a Human Factors SOP
The key Human Factors documents in the SOP
The Application Specification
The Task Analysis
The Human Factors Plan
The Human Factors Testing Strategy
The Human Factors Summary Report

DAY TWO (8:30 AM – 4:30 PM)


8.30 am – 8.45 am: Meet & Greet
8.45 am – 10.15 am: Defining the Key Components for Testing
Who Will Conduct the Testing?
Define Participant Criteria
Collect the Necessary Documents
10.15 am – 10.30 am: Break
10.30 am – 12.00 pm: Human Factors Formative Testing
Define the Goals and Methodology
Define the User Groups
Collect the Necessary Testing Components
Analyze the Results
12.00 pm – 1.00 pm: Lunch
1.00 pm – 2.45 pm: Human Factors Summative Testing
Define the User Groups
Collect the Key Documents:
uFMEA,
Application Specification
Task Analysis
Product Description
Define Use Scenarios
2.45 pm – 3.00 pm: Break
3.00 pm – 4.30 pm: Human Factors Summative Testing
Collect the Data
Analyze the Results
Create the Human Factors Summary Report

Seminar Summary:

The benefits of this course include the following:Show you how Human Factors can actually decrease development time and overall product development costs.Show how to plan and execute strategic Human Factors testing cycles. (see full course description)

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