TWI has decades of experience in helping medical equipment companies to meet their technology challenges and regulatory compliance challenges to manufacture cost-effective products.
There is a requirement to ensure medical technology products are manufactured in line with the relevant quality systems and standards such as ISO 13485.
Such regulatory affairs cross global markets to cover vital product safety measures for items including, for example, in-vitro diagnostic medical devices and TWI's quality and standards team are able to help make sure your products and manufacturing methods comply.
We work with the medical device industry to solve diverse product development problems, including responding to medical device recall.
Key industry sub-sectors within TWI Medical include orthopaedics, diagnostics, active implantable devices, reusable and single use healthcare support devices, surgical instruments and drug delivery products, although we have worked on projects in most medical specialities.
Our input into the product and device development process ranges from simple advice on the selection of materials and joining technology, through to the design and prototyping of new products, and business planning and process support.
Among our wide range of services, TWI can assist in product development, device consultancy services and quality management for medical technology.
TWI's team has an in-depth knowledge of collaborative research and development, ranging from expertise in consortium building and bid writing through to large-scale programme management, and is happy to talk to medical device manufacturers interested in knowing more about collaborative R&D funding.