We have the skills and experience needed by leading organisations in the medical industry: Creative and innovative thinking, meticulous project management and precision engineering.
We leave no stone unturned, using marketing studies, user research and technology evaluation to provide an objective assessment of a product’s journey to market and develop pathways for future projects.
We aim to deliver optimum product performance and a great user experience. Our systems are aligned with industry standards including ISO 14971, IEC60601 and FDA design controls, and are designed to create groundbreaking new medical products.
Packaging and IFU
Our involvement in new product development extends to areas such as outer packaging and instructions for use. The devil is in the detail and it is widely recognised that they contribute significantly to a positive user experience.
“Our work at Shore encompasses all key elements of development, from the product and IFU through to out of box experience. It’s inspiring to see the differences our designs can make.”
Scott Martin – Lead Designer
In an increasingly demanding market, our ability to leverage new technologies enables us to meet the challenge of building sophisticated medical products within the strict timescales imposed by our clients.
Regulatory and Compliance
In the complex and sometimes bewildering world of regulations and compliance, we offer support and clarity to our clients. This covers areas such as submission preparation, electronic compliance testing and product certification.
Usability and Human Factors Engineering
This key area of our work focuses on interaction between the individual and the product, and the ability of the device to administer a treatment as safely and effectively as possible. We work to ISO 62366, worldwide usability standards and FDA regulations.
One important factor that sets us apart from many of our competitors is our ability to supply components and complete devices to clients for clinical trials or commercial release. This service is managed through our ISO 13485 certified supply chain.
“The clear design of this blood glucose meter is exemplary. Its use can be grasped intuitively, and the measurement results are easy to understand.”