HARMAC MEDICAL PRODUCTS, INC.

Harmac Medical Products is a full-service contract manufacturer of single-use medical devices serving global markets. Founded in 1981, the company operates 4 manufacturing sites—USA (Buffalo, NY), Ireland (Castlerea), and Mexico (Tijuana, two facilities)—with 1,200 employees and 250,000 sq ft of manufacturing space. Harmac provides end-to-end services: design and development, tooling and automation, manufacturing and assembly, value engineering, process and product validation, and packaging and sterilization. The company specializes in seven therapeutic areas: Fluid Management (single-use fluid delivery devices), Wound Care (negative pressure wound therapy devices), Oncology (chemotherapy, biopsy, supportive care), Ophthalmic (canisters and cassettes), Diagnostic (Point of Care and In Vitro Diagnostic cartridges), Respiratory (airway management, ventilation, oxygen delivery), and Extracorporeal (cell therapy and blood purification). All facilities are FDA-registered, ISO 13485-certified, 21 CFR Part 820 and 21 CFR Part 11 compliant, with ISO 14644 Class 8 cleanroom capabilities. Harmac manufactures devices with PMA, 510(k), and CE markings. The company emphasizes lean manufacturing, Design for Manufacturing (DFM), Design for Assembly (DFA), and vertically integrated operations to streamline supply chains and shorten lead times. Quality management and continuous improvement are core to operations.