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Drug Delivery System Human Factors and Usability Requirements Training

Whether you designed your drug delivery system in-house or contracted with a medical device manufacturer, it is vital to understand how your users interact with your system to ensure it functions properly and that all potential safety issues are understood. Human factors studies are part of the design process and should be integrated into 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 Class on Drug Delivery IEC 62366-1:2020 Compliance Class

SkillsLab Class ?

Class Content


Class Duration

5 Half-Days*

Teaching Format

Live, Instructor-Led

Delivery Options

Virtual or In Person**

Certification of Completion


Continuing Education Units (CEU)


* 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 Usability Principles for Drug Delivery Systems Training Classes

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!


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

Course Overview

Here's What We Cover in This Training Class on IEC 62366-1:2020 for Drug Delivery Products

Usability / human factors analysis is becoming an area of focus within standards and global regulations. Learn what it takes to meet usability requirements of IEC 62366-1, and understand how they relate to ISO 13485, ISO 14971, EU MDR, FDA, and ICH.

Course Overview
SkillsLab Class

The Process Approach

  • Process approach to the quality management system (QMS)
  • ICH guidelines Q10 and Q12
  • Combination product manufacturing scenarios
  • Importance of human factors and usability engineering (HF-UE)
Exercise! Common QMS Processes and Usability

Usability and Human Factors – Concepts, Standards, and Requirements

  • Overview of human factors / usability engineering
  • Regulatory requirements related to usability
Exercise! Preventing Usability Problems

IEC 62366-1:2020 Clauses and Their Interpretation

  • Clause-by-clause overview of the IEC 62633-1:2020 standard
  • Supporting documents to the standard (guidance, etc.)
Exercise! Identify Hazard-Related Use Scenarios

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 with Usability

  • Premarket process links with usability engineering
  • Postmarket process links with usability engineering
Exercise! Usability and Product Life Cycle

Demonstrating Compliance to Usability Requirements

  • Expectations of the US FDA and notified bodies
  • Combination product considerations
Exercise! Review Usability Procedure; Summary of Usability Engineering File (UEF) Components
Exercise! Identify Combination Product Critical Tasks
What You Will Learn

What You Will Learn

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

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

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

Illustrate the interactions between risk management and usability engineering

Practice documenting potential failure modes in usability and their effects

Describe the links between design usability, risk management, and complaints

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 pharmaceutical and medical 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
  • Tech Services Personnel
  • QA/QC Managers
  • Tech Services Personnel

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