Human Factors & Usability

Human Factors
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.

Usability Engineering
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.

Regulatory Landscape
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.

Process
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.

On-Site Facilities
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.

Services
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For more information on PDD's usability engineering process click here.

 

News & Insights

27/07/2017

PDD completes its transition to the 2016 version of ISO13485 for Medical Devices.

PDD has completed its planned transition to the latest version of this rigorous international quality assurance standard for medical devices, building on the success of earlier transitions and successful audits to the FDA 21CFR Part 820 in 2015.

16/05/2017

Learning from real world use – complementing medical device experience databases through analysis of social media

An extract taken from Chris Vincent's knowledge piece that discusses the growing use of digital platforms such as social media to understand how people really use medical products.