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IEC 62366-1:
Prioritizing Usability in Medical Device Design

Mastering Usability Engineering for Medical Devices

IEC 62366-1 is an essential standard for usability engineering concerning medical devices. It focuses on ensuring that devices are designed with user needs and capabilities in mind, thereby enhancing safety and overall user experience.


MedLaunch is dedicated to helping medical device manufacturers implement the principles of IEC 62366-1. Our approach ensures that your products are not only functionally effective but also intuitively usable, aligning with both user satisfaction and regulatory requirements.

Image by Arseny Togulev

Designing for Safety and Efficiency

IEC 62366-1 compliance is more than a regulatory checkbox; it’s about embedding user-centered design into the heart of medical device development. This standard guides manufacturers to identify and mitigate risks associated with usability. It covers aspects from user interface design to end-user interaction.


Adhering to IEC 62366-1 is crucial for enhancing the safety, effectiveness, and user experience of medical devices. At MedLaunch, we provide expert guidance throughout your device development process, ensuring your products meet these important usability standards.

Streamlining Usability in Medical Device Design

MedLaunch provides a comprehensive suite of services to assist medical device manufacturers in achieving and maintaining compliance with IEC 62366-1. Our expert team guides you through every step of the usability engineering process, from initial analysis to final validation, ensuring your product not only meets regulatory requirements but also exceeds user expectations.

Customized Usability Engineering Solutions
  • Usability Planning and Analysis: We begin with a thorough analysis of user needs and product requirements, establishing a solid foundation for usability planning. Our team identifies potential usability challenges early in the design process, allowing for proactive risk mitigation.

  • User Interface Design and Optimization: Leveraging industry best practices and innovative design solutions, MedLaunch assists in developing user interfaces that are intuitive, efficient, and tailored to your target user groups.

  • Comprehensive Usability Testing: From formative evaluations during the design phase to summative validation studies for regulatory submission, our usability testing protocols are designed to rigorously assess the usability of your medical devices according to IEC 62366-1 standards.

  • Documentation Excellence: We provide detailed documentation support, including usability engineering files, to ensure comprehensive reporting of usability activities, outcomes, and compliance with regulatory expectations.

  • Training and Empowerment: MedLaunch offers specialized training sessions and workshops to empower your team with the knowledge and skills required for successful usability engineering, fostering a user-centered culture within your organization.

Why Focus on Usability?

The incorporation of usability engineering into medical device design is not only a regulatory requirement; it's a commitment to patient safety and quality care. Devices designed with user needs at their core are more likely to be adopted, correctly used, and less prone to user error, ultimately leading to better healthcare outcomes. We think that is something we can all agree on.

Why Partner with MedLaunch for Usability?

With MedLaunch by your side, navigating the complexities of IEC 62366-1 becomes an opportunity to distinguish your medical devices in the market.


Our tailored approach ensures that your products are not only compliant but also deliver an exceptional user experience, setting a new standard in user-centered medical device design.


Contact us to learn more about how we can transform your usability engineering processes and elevate your products to meet global usability standards.

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