Usability Engineering for Medical Devices: Applying IEC 62366-1

Usability engineering is an essential part of medical device development. It helps ensure that devices can be used safely and effectively by the intended users, for the intended purpose, and within the intended use environments. Poor usability can contribute to errors, hazardous situations, reduced performance and risks to patients, users, or third parties.

IEC 62366-1 provides a structured framework for applying usability engineering to medical devices. It supports the identification, evaluation, and control of use-related risks throughout the device lifecycle and is closely linked to risk management according to ISO 14971.

This training provides medical device professionals with a practical understanding of usability engineering principles and the application of IEC 62366-1 within design and development. Participants will learn how to establish a usability engineering process, define users and use environments, identify use-related hazards, plan and conduct usability evaluations and prepare the documentation needed to support regulatory submissions, audits, and technical documentation reviews.

Key Topics Covered:

• Principles of usability engineering and human factors for medical devices

• Overview of IEC 62366-1: scope, structure, terminology and key requirements

• Intended users, use environments, user interface characteristics and use scenarios

• Identification of use errors, use-related hazards, hazardous situations and critical tasks

• Integration of usability engineering with ISO 14971 risk management

• Formative usability evaluations: purpose, planning, methods and documentation

• Summative usability evaluation / usability validation: planning, execution, acceptance criteria and reporting

• Usability Engineering File: structure, content and documentation expectations

• Link between usability engineering, design controls, risk management, clinical evaluation and post-market surveillance

• Common usability-related nonconformities and gaps identified during audits and technical documentation reviews

• Practical case studies, interactive exercises and Q&A sessions

Benefits:

• Understand the principles and regulatory expectations of usability engineering for medical devices

• Learn how to apply IEC 62366-1 throughout the medical device development lifecycle

• Understand how usability engineering links to ISO 14971 risk management and design controls

• Improve the planning, execution, and documentation of formative and summative usability evaluations

• Learn how to structure the Usability Engineering File for technical documentation and regulatory reviews

• Strengthen the ability to identify, evaluate and reduce use-related risks

• Recognize common usability-related documentation gaps and audit findings

Certificate: Participants receive a Certificate of Attendance of DQS MED GmbH

Target Audience: Software engineers, architects, systems engineers, testers, and project managers involved in medical device software, regulatory affairs, quality management, risk, audit, cybersecurity and technical documentation professionals. Professionals preparing or reviewing software documentation for MDR compliance and Notified Body submissions. Applicable to embedded, standalone, health, and AI-enabled medical device software. Suitable for beginners and experienced professionals applying IEC 62304 and IEC 82304-1. Basic knowledge of medical device development, QMS, risk management, or software engineering is beneficial.