Medical device manufacturer eliminates paper-based Device History Records, cutting documentation time from two weeks to real time while strengthening audit readiness

Cartago, Costa Rica, Oct. 15, 2026 (GLOBE NEWSWIRE) -- Biomerics, a leading contract manufacturer of medical devices, has completed an extensive validation process and gone live with Eyelit Technologies'Manufacturing Execution System (Eyelit MES), including full electronic Device History Record (eDHR) functionality. The go-live achieves the original goals of the project and marks a significant step toward fully compliant, paperless production at Biomerics' Costa Rica operations.

Prior to implementation, Biomerics relied on paper-based DHRs that could run 100 to 500 pages per record and take up to two weeks to compile, tying up resources that could otherwise support the production floor. With Eyelit MES now live, that manual compilation burden is gone, freeing staff to focus on production while reducing the risk of documentation errors.

Compliance is now built into the manufacturing process itself rather than handled as a separate post-production step, and an immutable blockchain record of production data, backed by compliant electronic signatures, reinforces conformance with ISO 13485, 21 CFR Part 11 and 21 CFR Part 820/QMSR. Validation is managed within the same system used for production, giving Biomerics a single auditable record rather than a parallel paper trail, and staff time once spent on documentation and post-production verification is now available for continuous improvement.

The Biomerics go-live reflects Eyelit's broader Manufacturing Operations Management (MOM) approach, in which MES serves as the foundation for further expansion into planning, scheduling, and execution improvements powered by Agent EyeQ, giving manufacturers a single platform to grow into as operations mature.

About Eyelit Technologies

Eyelit Technologies is a leading provider of integrated software solutions that optimize factory and multi-factory productivity across industries such as semiconductor, automotive, medical device, electronics, and aerospace & defense. Its AI-powered suite of planning, scheduling, and execution solutions enables businesses to improve production processes, enhance asset utilization, and streamline scheduling. Eyelit Technologies empowers organizations to drive profitable growth, reduce costs, improve delivery performance, and gain greater visibility, improved decision support, and decision execution.

Expanding on this foundation, Eyelit's purpose-built, industry-specific solutions extend the capabilities of existing platforms to optimize decision-making across supply chain, planning, and execution. These tailored solutions improve outcomes by addressing critical elements such as orders, quality, assets, materials, labor, and suppliers. To learn more, visit: www.eyelit.com

About Biomerics

Founded in 1994, Biomerics is a leading vertically integrated contract development and manufacturing organization serving the global interventional medical device market. As a trusted strategic partner to 20 of the world's top 30 medical device OEMs, Biomerics helps customers accelerate innovation, reduce complexity and bring life-changing technologies to market.

Biomerics provides end-to-end capabilities spanning engineering design and development, technology transfer, manufacturing, sterilization, packaging, and commercialization of medical device components, subassemblies and finished devices. Through an integrated network of 12 manufacturing facilities across the United States, Costa Rica and the Dominican Republic, the company delivers scalable solutions that support customers from concept through commercial production.

With world-class engineering Centers of Excellence, Biomerics is a recognized leader in advanced polymers and materials, precision extrusion, balloons and balloon catheters, advanced catheters and steerables, guidewires, laser processing, micromachining, micro-overmolding, precision stamping, metal injection molding (MIM), image-guided intervention technologies, complex microassembly, and finished device manufacturing.

Operating under a certified ISO 13485:2016 Quality Management System and compliant with applicable FDA medical device regulations, Biomerics is committed to improving and saving lives by delivering exceptional customer experiences, advancing innovation and achieving manufacturing excellence.

Contact:
Johanna Coutinho
Eyelit Technologies
6478810894
jcoutinho@eyelit.com