Medical device products have a wide range of unique manufacturing requirements. Regulatory requirements for varying degrees of cleanliness and sterility have a direct impact on the design of the manufacturing environment and process equipment.
DME employs good engineering practice for GMP facility design and leverages in-house subject matter expertise in key technologies required for the delivery of safe, efficient, and compliant facilities. Our process core competencies are also well aligned with projects involving medical device products that are regulated as combination products, or therapeutic and diagnostic products that combine drugs, devices, and/or biological products. Choose DME for engineering excellence on your next medical device facility design project.