Manufacturing Framework
For medical devices, often the difference between life and death, safety is naturally a top priority. Reflecting this fact, manufacturers of pharmaceuticals and medical equipment are governed by a set of GMP guidelines to ensure proper manufacturing and quality control standards are maintained. Based on these guidelines, Japan MDM formulated its own set of stringent voluntary standards, and in July 2004 obtained the internationally recognized ISO13485 certification for its quality management system for medical devices. These actions embody Japan MDM's efforts to reliably maintain product quality.
From raw materials and processing to assembly, packaging and shipment, U.S.-based Ortho Development Corporation's plant (ISO9001/ISO13485/CE Marking certified) and Japan MDM's Tsukui Plant (ISO9001/ISO13485 certified) in Kanagawa, Japan, utilize the latest equipment to rigorously manage quality at every stage. The result is a highly reliable manufacturing framework able to clear most tests and inspections with flying colors.
In its products, Japan MDM pursues a level of quality that meets or exceeds global standards. The goal here is to deliver products that are highly rated on all fronts and that fully meet needs worldwide.