Contract Medical Device Manufacturing Services Agreement

A comprehensive OEM-EMS contract framework designed specifically for FDA-regulated medical device manufacturing programs. 36 pages. This agreement covers the full scope of the OEM-EMS manufacturing relationship - from how products are priced and ordered, through how forecasts drive material procurement and inventory liability, to what happens when components fail in the field at epidemic rates. It addresses the regulatory and compliance obligations unique to medical device manufacturing, including provisions for U.S. FDA, EU MDR, and MDSAP requirements. The agreement includes structured exhibits for program-specific pricing, component lead-time management, product specifications, customer-furnished equipment, and quality and regulatory standards - each designed to be customized to your program before execution. Built from real OEM-EMS manufacturing engagements, not from a legal template library.