Developing Safe and Effective Medical Devices With Usability Engineering

We Work With all Types of MedTech Development, Including Devices, IVD, Combination Products and Software

It is not enough that your medical device has the right features if the users are not able to use them correctly. In the interaction between the user and the device, it is critical to account for human capabilities and limitations. Hence, evaluating the User Interface should get as much attention as designing the device.

What We Offer

We will help you integrate Usability in your device development and at the same time document the process to ensure compliance with authorities.

Our services range from early-stage user insights and formative User Interface evaluations to late-stage summative evaluation, HFE reporting and authority dialogue. We often assist in existing product updates and design changes.

MGS Design & Development is working in compliance with recognized Human Factors and Usability Engineering standards and guidances (FDA guidance & IEC 62366-1:2015).

Expert Knowledge and Extensive Experience

Our expert knowledge and extensive experience enable us to advise our clients on both the strategic and operational level. When working with Usability Engineering, we make sure to integrate the activities with Design Control and Risk Management. We utilize input from Risk Management to scope the Usability Engineering activities and make sure that the output from these activities provide valuable input for both the User Interface Specification and Risk Analysis. Our in-house product development capabilities furthermore enable us to provide redesign suggestions to improve the usability of your device.

For user testing, MGS Design & Development can also provide test facilities and test recruitment assistance both in Europe and in the US. We also offer Usability courses, tailor-made to suit your company needs and product category.

Focusing on and prioritizing Usability Engineering activities will generate numerous benefits:

• Minimized need for training and support.
• Fewer late stage changes in the development, ultimately leading to faster time-to-market.
• Regulatory compliance: Even though it is not always required to submit Usability Engineering documentation to authorities, documentation is still mandatory and can be requested by authorities during e.g. inspections and audits.
• Simpler and more intuitive product user interfaces.
• Improved user satisfaction leading to improved sales.
• Improved market life and customer loyalty.
• Minimized risk of liability claims and product market withdrawals.