Global footprint Biomerics operates nine U.S. locations plus sites in Costa Rica, the Dominican Republic and Ireland, enabling global manufacturing and nearshoring options for interventional device OEMs. Their end-to-end capabilities cover design, development, tech transfer, contract manufacturing, sterilization and packaging, supporting faster time-to-market and resilient supply chains. With ISO 13485:2016 and FDA registration, Biomerics helps OEMs meet regulatory requirements under one trusted partner.

Advanced capabilities The company has expanded materials and microfabrication with the Quadrathane TPU line for long term implantables and vertically integrated Metal Injection Molding. Centers of Excellence in materials, advanced catheters, micromachining and microassembly enable design to high volume production of complex interventional components such as guidewires, balloons, steerables and finished devices. This broad technical capacity opens opportunities for customers needing high reliability, miniaturization and bespoke biomaterials.

Regulatory ready Biomerics operates under a certified ISO 13485:2016 quality system and is FDA registered with 21 CFR Part 820 compliance. This strong quality backbone reduces regulatory risk for clients and supports rapid scale up from prototypes to manufactured devices. For potential customers, Biomerics can shepherd engineering to production with established quality systems and validated sterilization and packaging.

Growth leadership Recent leadership appointments including President of International Division and General Manager of key facilities, plus the creation of a dedicated Micro Metals Division, signal aggressive capacity expansion and multi regional coordination. Combined with previous Minnesota facility expansion and new product lines, Biomerics is positioned to take on larger programs and multi site manufacturing opportunities for global OEMs.

Market focus Biomerics serves major interventional markets including Cardiovascular, Neurovascular, Endoscopy, Robotic Surgery, Structural Heart, Urology and Vascular Access, already supplying about 20 of the top 30 device OEMs. This portfolio supports cross selling across product families and markets, offering a single partner for design through finished device assembly. Leverage these relationships to target OEMs pursuing diversification, nearshoring or expanded product lines.