Contract Medical Device Product Design Services Agreement

Contracts and Legal Frameworks | PDF | $249

When an OEM company hands product design to a third-party provider, the contract governing that engagement determines who owns the IP, who controls the source code, and what happens when the provider cannot deliver. Most design service agreements leave these questions partially answered. The answers only matter when something goes wrong, and by that point the ambiguity works against you.

This agreement governs the full design engagement for FDA-regulated medical device programs, from how the scope of work and deliverables are defined, through design control and review processes required under FDA and EU MDR regulations, to how intellectual property is assigned between manufacturing IP and product-unique IP. It establishes milestone-based payment controls tied to accepted deliverables, escrow provisions protecting source code in the event of provider insolvency, cybersecurity protections for design data, and confidentiality provisions specific to medical device development programs. Built from real OEM-provider design engagements where clarity in the agreement prevented disputes during execution

Who this is for

OEM medical device companies engaging third-party providers for product design services.

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