What is Carville’s Medical Track History?
Carville have been supplying the medical device market since 1980, including developing the world’s first diffusion bonded medical manifold for Corning Medical followed by more complex solutions for Bayer/Siemens. We have also supplied many class III implants such as knee and eyeball replacements as well as components for specialist reading glasses and life support systems. The medical market is one of the prime markets for Carville and this continues to grow.
Medical Device Development
We understand the rigour, quality, verification and validation requirements of medical device development, and the considerable time from concept to market, which is often many years. Carville is flexible to support the early design and prototype stages to help early selection of materials, designs and processes to support the longer term production needs. We are also keen to understand how our products fit into the overall system so we can optimise interfaces and recommend solutions to clients.
Carville’s ISO 9001:2015 certified QMS system is very robust and geared up to support our clients’ ISO 13485 requirements for FDA and CE approval, including full traceability, test reports, material and measurement reports. As our parts are often defined as critical components in class II medical devices, we also support un-announced FDA and EU notified body audits of our facility and processes in agreement with clients and have an outstanding performance record for these audits.
What kind of products do you supply to medical device companies?
Carville supply three main categories of plastic parts for medical devices, these are medical manifolds, microfluidic chips, precision machined plastic components and medical quality assurance phantoms for calibration.
For Carville, these are high accuracy diffusion bonded, multilayer fluidic manifolds without the use of any adhesives. They can bring together multiple sub-systems including pneumatic control, bodily fluids, cooling systems, specific chemistry and medical gases. These can be re-useable, instrument based manifolds, or disposable and can include microfluidic channels. The can be used in Point of Care (PoC) devices, treatment systems, monitoring equipment and testing. For more information see Medical Manifolds page.
Precision machined plastic medical components
Many medical device instruments require high precision machined plastic parts in various materials such as PEEK, POM, Nylon, Acrylic, Polycarbonate, often with biocompatibility requirements to ISO 10993. Carville have the ability to supply these parts to very tight tolerances with absolute repeatability to ensure performance.
Medical quality assurance phantoms
Radiographers and technicians use medical phantoms to set-up and calibration imaging and therapy systems, such as X-Ray, MRI, CT and radiotherapy to ensure that the systems are accurate prior to patient use, often on a daily basis. These can take many forms and use different plastic such as Acrylic or Polystyrene, but they all have the requirement for a very high level of machining and fabrication accuracy, which Carville deliver. Clients include global names such as Varian and Elekta as well as some of the smaller newcomers to the imaging market. For more information, see our Medical Phantoms page.