KOYA MEDICAL, INC

Koya Medical, Inc. specializes in the manufacturing of surgical appliances and medical supplies, with a demonstrated focus on producing high-precision equipment for clinical and patient care environments. Their technical expertise lies in the design, fabrication, and delivery of FDA-regulated medical devices and consumables that meet stringent federal healthcare standards, including those governing sterility, biocompatibility, and durability. The company’s capability centers on fulfilling complex procurement requirements for durable medical equipment, particularly items classified under Federal Supply Schedule (FSS) programs, indicating a strong understanding of government procurement workflows and compliance with FAR and 21 CFR Part 820 quality system regulations. Their ability to deliver on FSS contract awards suggests proficiency in scalable production, inventory management, and rapid fulfillment for distributed federal facilities. Koya Medical has established a direct working relationship with the Department of Veterans Affairs, supplying critical medical equipment to VA healthcare networks. This engagement reflects a proven ability to meet the VA’s operational needs for durable, reliable, and standardized surgical supplies used in outpatient clinics, VA hospitals, and long-term care settings. The nature of the award indicates a focus on routine yet mission-critical items that support daily clinical workflows, suggesting a partnership built on consistent quality and reliable logistics. The company’s primary industry focus is in surgical appliance and supplies manufacturing, a niche within the broader medical device sector that requires precision engineering and strict adherence to ISO 13485 and FDA Quality System Regulation standards. Koya Medical positions itself as a specialized supplier of essential clinical tools rather than broad-spectrum medical technology, serving a targeted segment of the federal healthcare supply chain. As a small business structured as a 2L entity based in Oakland, California, Koya Medical operates with a lean, focused model. While it currently holds no formal government certifications, its successful award under the FSS program demonstrates compliance with federal procurement requirements and an established presence in the federal medical supply market.