ACTUATED MEDICAL, INC.

Actuated Medical, Inc. specializes in preclinical research and development services for medical devices, with deep expertise in biocompatibility testing, animal study design, and sterilization validation protocols. The company delivers end-to-end regulatory support for early-stage medical technologies, conducting rigorous in vitro and in vivo evaluations to meet ISO 10993, ASTM, and FDA guidance standards. Their technical proficiency spans toxicology assessment, microbiological sterility testing, and protocol development for investigational devices, enabling clients to navigate premarket submission pathways with data-driven evidence. A key differentiator is their focused application of scientific rigor to the Blueprint MedTech initiative, where they translate regulatory requirements into actionable research frameworks that accelerate device approval timelines. The contractor maintains a strong, consistent relationship with the Department of Health and Human Services, delivering mission-critical R&D services aligned with public health innovation goals. Their work supports HHS initiatives focused on advancing safe, effective medical technologies through structured preclinical development, indicating a trusted partnership in supporting federal medical device modernization efforts. Actuated Medical’s primary focus is in NAICS 541715, which encompasses applied life sciences research excluding biotechnology and nanotechnology. In practice, this means they serve the medical device sector by providing non-clinical validation services essential for FDA clearance—particularly for Class II and III devices requiring substantial equivalence or PMA pathways. Their market positioning is niche but critical: they bridge the gap between engineering prototypes and regulatory readiness through scientifically robust, compliant testing programs. As a Women-Owned Small Business and Woman-Owned Business certified firm based in Bellefonte, Pennsylvania, Actuated Medical leverages its small business status to deliver agile, tailored R&D solutions within federal procurement frameworks. The company’s certification underscores its commitment to diversity in federal contracting while maintaining a focused operational footprint centered on high-integrity life sciences research.