May 9, 2024

IEC 62366-1 Essentials: Elevating User Safety in Medical Devices

Are you harnessing the full power of IEC 62366-1 to enhance user safety and improve device usability in your medical device development?

In an industry where the margin for error is minimal and user safety is paramount, understanding and implementing IEC 62366-1 can be the game-changer your projects need.

Join us for an insightful webinar where medical device development experts from CLEIO will dive deep into IEC 62366-1, guiding you through the intricacies of the regulatory framework and risk management around the standard.

Whether you’re looking to refine your current processes or integrate new methodologies, this session will provide you with the knowledge and tools you need to apply this critical standard effectively to make your devices safer and more user-friendly.

Specifically, this webinar will cover:
  • Overview of IEC 62366-1: Explore key elements of the standard and its practical implementation in enhancing medical device usability.
  • Types of Use Errors: Understand the three main types of use errors identified in medical device usage
  • Enhancing User Safety: Learn about the safety benefits that IEC 62366-1 brings to users and its importance in medical device design
  • Collaboration between QA & HF: Discover how Quality Assurance (QA) and Human Factors (HF) integrate to strengthen medical device development
  • Navigating the Regulatory Landscape: Get an overview of the regulatory framework and the essentials of risk management
  • Mastering Usability Engineering Validation: Gain key insights into formative and summative evaluations and their critical roles in the design process
  • Top Tips for User-Centered Design: Acquire practical strategies to optimize your development process with a focus on User-Centered Design

Watch the webinar

IEC 62366-1 Essentials Elevating User Safety in Medical Devices
Who should attend?
  • Medical Device Executives
  • Product Development Engineers and Management
  • R&D Engineers and Management
Register Now  

Hosted by

Etienne Nichols

Medical Device Guru,
Greenlight Guru

Jean-Yves Pairet
Jean-Yves Pairet

Quality Assurance Director,

Maude Leclerc-De Guire
Maude Leclerc-De Guire

Human Factor Specialist,

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About Greenlight Guru

Greenlight Guru is the leading cloud-based platform purpose-built for MedTech companies. The end-to-end solution goes beyond traditional QMS needs by integrating cross-functional teams, processes, and data throughout the entire product lifecycle so device makers can proactively overcome execution gaps, streamline compliance, and accelerate market success.

Greenlight Guru’s platform is used by organizations across the globe that are replacing their disjointed, legacy tools and solutions to bring life-changing products to people faster, and with less risk.

Visit our homepage to learn more.



CLEIO is a leading medical device development firm gathering over 90 experts divided into several locations across North America. Over the years, CLEIO has been involved in more than 2,500 projects with a single desire: shaping our future by designing innovative medical devices.

With an integrated and ISO 13485-certified approach to medical device development, CLEIO combines strategy, design, engineering, and quality assurance to deliver exceptional results. Their extensive experience in various fields, including oncology, respiratory, cardiovascular, and digital health systems, makes them the partner of choice for medical device and software development.

Visit their website to learn more.

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