Are the parts Carville supply suitable for medical devices or IVD applications?

Carville have been producing precision machined plastic parts and bonded manifolds for medical devices for almost forty years.  These are often critical to function  components in class III medical devices so must adhere to the strictest standards in terms of processes, materials and procedures.   We support our client’s ISO14385 requirements with full documentation and full traceability on the entire process from certified in bound material to final despatched parts including full dimensional reports when required.  We are also subject to unannounced audits by notified bodies including the FDA to support our clients.