usability engineering - in short

Usability Engineering is critical in developing safe and effective medical devices

Usability Engineering is a vital aspect in obtaining safe and effective medical devices and fulfilling requirements from authorities. FDA and Notified Bodies have increased their focus on Usability Engineering and they expect that you validate that the intended users can use your product as intended in the intended use environment.

 

Usability Engineering with Technolution
Usability engineering

Our capabilities

Whether your organization needs a single of our competences or the entire range, we are here to help you. 

User Research and Use Specification

Strategy and Planning

Integration with Design Control and Risk Management

Task Analysis and Use Error Risk Analysis

User Interface Specification and Design 

Heuristic Evaluation and Expert Reviews

Formative Tests

Usability Test Protocol

Summative Evaluation

Human Factors Documentation and Reporting

Usability Engineering Training and Courses

Summative Evaluation

usability engineering - the long read

We work with all types of MedTech development, including devices, IVD, combination products and software

We will help you integrate Usability Engineering 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.

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

Why focus on Usability Engineering?

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.

Expert knowledge and extensive experience

Enable us to advice 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, Design and Risk Analysis. Our inhouse product development capabilities furthermore enable us to provide redesign suggestions to improve the usability of your device.

For user testing, Technolution can also provide test facilities and test recruitment assistance both in Denmark and through our network within the EU and in the US.

We also offer Usability Engineering courses, tailor made to suit your company needs and product category.

Focusing on and prioritizing Usability Engineering activities will generate numerous benefits:
Want to know more?

Get in touch

Do you want to know more or didn’t you find what you were looking for?

As Head of Usability Engineering, Jon is prepared to receive your enquiry. 

What we do

We have nine areas of expertise that takes you from A-Z

We advise at all levels, regardless of the need for either a single competence or a full project. Depending on the size of the project, we constitute the right team of specialists.

What we do

We have nine areas of expertise that takes you from A-Z

We advise at all levels, regardless of the need for either a single competence or a full project. Depending on the size of the project, we constitute the right team of specialists.

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