MEDSPIRA, LLC

MEDSPIRA, LLC specializes in the design, development, and manufacturing of advanced medical devices and diagnostic equipment, operating under NAICS 339112 for Surgical and Medical Instrument Manufacturing. The company’s core capabilities center on precision engineering of FDA-regulated devices, including electro-mechanical systems, sensor-integrated instrumentation, and sterile-packaged diagnostic tools. Their technical expertise includes compliance with ISO 13485 quality management standards, design control processes per 21 CFR Part 820, and regulatory documentation for 510(k) submissions and CE marking. MEDSPIRA differentiates itself through lean manufacturing practices, rapid prototyping of implantable and point-of-care devices, and integration of biocompatible materials in high-reliability applications. The firm emphasizes end-to-end product lifecycle management, from concept validation through post-market surveillance and design updates. No award history is available to infer specific agency engagements, so no definitive relationships with federal departments can be confirmed. Consequently, there is no verifiable pattern of work performed for agencies such as DOD, VA, or HHS. The company’s primary industry focus is medical device manufacturing, with practical specialization in Class II diagnostic and surgical instruments requiring rigorous validation and traceability. MEDSPIRA positions itself within the high-compliance segment of the biomedical supply chain, serving OEMs and healthcare providers requiring validated, domestically produced equipment with full regulatory documentation. MEDSPIRA, LLC is a small business structured as a 2K entity, headquartered in Minneapolis, Minnesota. The company holds no federal certifications such as 8(a), HUBZone, or WOSB, and operates without formal government-recognized socio-economic designations. Its geographic footprint is concentrated in the Upper Midwest, with supply chain and manufacturing operations localized to support just-in-time delivery and quality control for U.S.-based medical customers.