When you need to ensure patients understand your PIL’s, IFU’s, Implant Cards, Quick Reference Guides and SSCP’s

Once you have a prototype medical product, why not put it in front of users and gather some feedback on its design?

Validate your medical product in a Summative Usability Study to ensure it is effective in use and safe for all intended.

For compliance with US FDA Guidances, we perform Human Factors Validation Tests in the USA to exceed the FDA’s expectations

Want to know if your medical product is going to be safe and usable? An Expert Review may give confidence that it will achieve this

To predict future use, it is ideal to understand the current use of comparable medical products by researching this with users

When you need to understand the cognitive and physical capabilities of the user, it is ideal to gather data on their abilities and disabilities

To innovate and understand current user behaviours we observe them in their natural use environment to gather relevant data

When there are specific pieces of information are required to be investigated, then interviewing users works to gather this data

Before performing your Comparative Human Factors Study or your Validation Test, performing a Self-election Study is ideal

When applying for some regulatory submissions, testing for non-inferiority against a reference device is required

Data is ideally used to predict the future behaviors of users. It can be analysed to be used in software and in AI algorithms

To have usable documents that are supplied with the medical product, we create and test these documents to be useful and effective

We collaborate with medical, biotechnology and pharmaceutical organisations to design and develop user interfaces of the future