Human factors is not a stage in our process - it is a fundamental foundation that runs throughout the course of every project, from desk-based research through to post-market surveillance.
The concept of Usability Engineering (UE) brings together Human Factors, Risk Management and User Experience design to understand and optimise how users interact with medical devices. UE is a regulatory requirement and PDD can fully integrate UE throughout the medical device design and development process or support stand-alone usability testing for your own development projects.
PDD has a comprehensive understanding of IEC62366 and ISO14971 which are both harmonised under the Medical Device Directive. PDD operates in compliance with the FDA and design guidance documents such as HE75.
In-line with regulatory requirements to develop a UE file for pre-market submissions, we can provide you with a full suite of regulatory documentation to suit the needs of your project.
There are two usability testing rooms at our London studio.
The private rooms can be used for formative or summative evaluations and are equipped with twin ceiling mounted cameras and microphones for recording and remote client viewing.
A wide range of use-scenarios can be simulated such as the home, outdoors or hospital environments. Furthermore, our flexible spaces can facilitate focus groups, training sessions, workshops and interviews.
For more information on PDD's usability engineering process click here.