Medical Design
Shore has many years experience of developing numerous products within the medical device sector. All our projects are carried out within our accredited ISO 13485 development process.
Our in-house medical product design includes development of various medical devices including orthopaedic devices, blood glucose meters, drug delivery systems, point of care products, trauma devices, implantable devices and cardiac diagnostics.
Our involvement has covered all stages of development ranging from research and scenario definition, proof of concept, through engineering development and prototyping, into clinical trials and manufacture.
ISO 13485 Development Process
Our entire design & development process is fully accredited to ISO 13485 for medical device design and all developments carried out in accordance with the Medical Device Directive. We have extensive experience in creation and management of the design history file and we are able provide advice & support for your application for classification and entry to market.
Proof of Concept Development
An early step in the development of new medical technology products or those that challenge existing technology barriers, is a proof of concept model. These models allow a fast evaluation of the operating principles of any design and allow direct early entry into development. They are also invaluable in funding rounds or investor presentations.
Risk Assessment ISO 14971
To eliminate or reduce risks as far as possible by inherent safe design of medical devices, we carry out risk planning, hazard identification, risk assessment & management at all key stages in the design and development lifecycle. The risk assessment is an integral part of our design history file and is fully compliant with the Medical Devices Directive
User Centred Design
Medical Devices need to be easy to read, understand, set, maintain, and calibrate within the environment they are used. User Centred Design ensures that all relevant conditions of use are accounted for in the design of a medical device through iterative analysis and evaluation during the concept, development and production phases.
Engineering Development
Our engineers are a core aspect of our ISO13485 process to ensure the thoroughness of design control, risk assessment and design history file. Our knowledge in key areas ensures that all our products are able to perform exactly as intended. We are able to develop innovative & reliable solutions for products using standard and breakthrough technologies.
Verification Prototypes
To ensure a design meets product requirements, verification prototypes are made from production ready CAD in representative materials and finishes. Our verification test includes checks for Fit, Form & Function & physical performance testing. These prototypes are made using various processes, including CNC & soft tool injection moulding.
User Trials
A very important aspect of the medical design process is research focused on better understanding how the user interacts with the product and what kind of people use it, especially in the area of risk reduction. We are able to either carry out or support user trials & tests, and then incorporate any learning from the trial into the device design.
Manufacturing Support
Once full production is underway, we are still on hand to ensure that any issues are resolved to ensure ongoing product quality
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