Medical Device
Engineer Certainty Into Your US Manufacturing Market Entry
For European medical device manufacturers, US market access has always meant navigating a maze of FDA scrutiny, import complexity, and jurisdictional uncertainty. A Puerto Rico manufacturing site eliminates that maze entirely — your products are manufactured on US soil, under US jurisdiction, subject to the same regulatory framework the FDA already trusts. This isn't an expansion. It's a structural advantage your European competitors don't have.
Puerto Rico Advantages in Medical Device Manufacturing:
• US Jurisdiction, Zero Import Friction — No tariffs, no customs delays, no cross-border regulatory gaps
• FDA-Aligned by Design — Puerto Rico's regulatory ecosystem is built around FDA compliance, not adapted to it
• Decades of MedTech Talent — Workforce trained by the world's largest medical dev. manufacturers, ready for your operation
• Act 60 Tax Incentives — Aggressive corporate tax rates that materially improve unit economics from year one
