Contract Medical Device Manufacturing Services Agreement

Contracts and Legal Frameworks | PDF | $249

Most OEM medical device companies enter EMS manufacturing relationships using contracts drafted by the provider's legal team. Those contracts protect the provider. This agreement was built from the OEM side, from real engagements where the absence of specific provisions created problems that cost more to resolve than the manufacturing program was worth. It covers the full scope of an FDA-regulated 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 regulatory compliance across U.S. and EU jurisdictions, counterfeit prevention, cybersecurity for manufacturing systems, and IP protection with structured exhibits for program-specific pricing, long lead-time component management, specifications, customer-furnished equipment, and quality and regulatory standards. Each exhibit is designed to be customized to your program before execution.

Built from real OEM-EMS manufacturing engagements, not from a legal template library.

Who this is for

OEM medical device companies engaging contract electronics manufacturers for FDA-regulated product programs.

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