To enhance patient safety, medtech manufacturers depend on reliable sourcing of raw materials and components from suppliers that consistently meet production specifications. But there are currently no broadly accepted standards to guide the formulation, manufacture, selection, use, or reuse of materials in healthcare products.
Enter the North America Medical-Grade Materials Consortium (MGMC), an alliance of polymer industry suppliers whose initial aim is to define the criteria for what constitutes a medical-grade material. In turn, the consortium expects to work toward developing internationally harmonized standards for the use of such materials in a broad range of medical applications, including diagnostics, devices, robotic systems, and pharmaceutical packaging.
When fully harmonized, MGMC’s criteria and standards will help to ensure industrywide quality and consistency, and to simplify medtech manufacturers’ selection and use of appropriate materials for products in use across the globe.