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Medical Device Human Factors Usability and IEC 62366 Training

Usability and human factors analysis is becoming an area of focus within standards and global regulations. It is important to know how your users may interact with your device in order to ensure that the device functions properly and all potential safety issues are understood. Human factors studies are part of the design process and should be integrated into device risk analysis. This course provides an overview of the requirements of IEC 62366-1:2020, including the relationship with the risk management process.

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Brief Overview of This Medical Device Usability Requirements Training Course

SkillsLab Class ?

Class Content

In-Depth

Class Duration

5 Half-Days*

Teaching Format

Live, Instructor-Led

Delivery Options

Virtual or In Person**

Certification of Completion

Yes

Continuing Education Units (CEU)

2.4

* SkillsLab classes delivered in-person (private or public) are full-day sessions delivered over 3 consecutive days. 

** Interested in private training for your team, virtually or in-person at your facility? See more details or ask us about it!

Upcoming Classes

Upcoming Training Classes on IEC 62366-1 and Medical Device Human Factors

SkillsLab $3895

SkillsLab $3895

There are no public training classes scheduled right now but this class can be delivered privately to 6 or more people at any time. Ask us for details!

GROUP DISCOUNT

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25%

Register 3 people, 4th attends free!

Free

*This offer cannot be combined with any other promotional offer(s).

Course Overview

Here's What We Cover in This Training Class on FDA Human Factors and Medical Device Usability

Usability / human factors analysis is becoming an area of focus within standards and global regulations. It is important to know how your users may interact with your device to ensure the device functions properly and all potential safety issues are understood. Human factors studies are part of the design process and should be integrated into device risk analysis. This course provides an overview of the requirements of IEC 62366-1:2020, including the relationship with the risk management process. 

Course Overview
SkillsLab Class

Usability and Human Factors: Concepts, Standards, and Requirements

  • Introduction to usability
  • Definitions
  • Usability and human factors in global regulations
  • What can go wrong? Adverse events in human factors
Exercise! Cross-Reference Usability Requirements

IEC 62366-1:2020 Clauses and Their Interpretation

  • Clause-by-clause overview of the IEC 62366-1:2020 standard
  • Supporting documents to the standard (guidance, etc.)
Exercise! IEC 62366 Requirements

Usability Engineering Deliverables

  • Key terms
  • User interactions and use error causes
  • Usability engineering file
  • Usability testing strategies
Exercise! Create a User Profile and Use Specification
Exercise! Create a User Interface Error Analysis

Premarket and Postmarket Process Linkages

  • Premarket and postmarket process links with usability engineering and human factors
Exercise! Interrelationships Among Usability Engineering / Human Factors and Other Processes in the Medical Device Life Cycle

Demonstrating Compliance to Usability Requirements

  • Expectations of US FDA and Notified Bodies
  • Consensus standards
Exercise! Review Usability Procedure
Exercise! Summary of Usability Engineering File (UEF) Components
What You Will Learn

What You Will Learn

At the conclusion of this training class, you will be able to
SkillsLab

Describe the usability requirements in quality management system standards and regulations (IEC 62366-1:2020, ISO 13485:2016, ISO 14971:2019, EU IVDR Annex I, EU MDR, and FDA)

Provide an analysis of the requirements of IEC 62366-1:2020

Illustrate the premarket interactions between risk management, design and development, and usability engineering

Practice documenting potential failure modes in usability and their effects

Describe the postmarket links between design usability, risk management, and complaints / corrective and preventive actions (CAPAs)

Establish examples of traceability among user-related hazards, risk mitigations, product requirements, and verification / validation results

Determine procedures and evidence needed to demonstrate compliance to usability requirements in IEC 62366 1:2020 and related standards / regulations

Evaluate best practices in usability elements of premarket submissions

Who Should Attend

Who Should Attend

Anyone from the medical device and in vitro diagnostic device industries involved in development, including regulatory personnel. Recommended for staff with the specific responsibility of risk management, as well as quality engineering, technical services, operations, QA/QC, regulatory, and research and development. 

  • Regulatory Professionals
  • Quality Engineers
  • Operations Managers
  • QA/QC Managers
  • Tech Services Personnel
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