You want your product to look and feel good, work well and safely. We do too. Through our user research, technological expertise and design approach capabilities, we can help your product fulfil its potential. When it comes to medical device design getting it right is crucial. We can help you find solutions and enable your company to go from strength to strength.
At this stage you need to capture the project activities in a plan. A plan that describes the process you are going to follow. We can help you do this, taking care to ensure design activities (such as product design, risk and usability) and quality requirements (e.g. design reviews, design control procedures, supplier audits) are included.
Unsafe and ineffective devices often result from informal development that did not establishment real design requirements or did not assess device performance adequately. To combat this we follow a User Centred Design Process that helps you understand the whole user experience before you start designing.
We systematically identify who your users are and how they are likely to use your product, having access to a wide pool of patients, clinicians and healthcare professionals across a range of therapeutic areas. This provides a solid basis on which a device development project can be built.
We work with Design Controls ISO 13485:2016, Risk Management ISO 14971, Usability ISO 62366 and cGMP (Pharmaceutical Good Manufacturing Practice)