Tag: material selection

When selecting the materials that will make up a medical device, one of the most important steps is considering the FDA requirements for flammability, biocompatibility and environment compatibility.  These requirements are necessary for a marketable device, but not for a functional prototype. It is common during technology development to focus on core functionality and delay meeting some regulatory requirements until the product design stage. Once the product design commences, it is possible to experience difficulty finding materials that meet both core functional and regulatory requirements.