https://www.moldeddevices.com/2021/01/28/clean-room-assembly-and-molding-services-from-mdi/ : MDI holds ISO 13485 certification for clean room assembly and molding. Our team has years of experience bringing complex components and devices to market. We have several trusted outside vendors who provide us with metal components like hypotubes, needles, trocar shafts and tooling. Browse the website for more details.