Services
Our engineering firm offers a comprehensive suite of services designed to accelerate innovation in the life sciences. We specialize in medical device development, guiding concepts from design through prototyping and testing to ensure safety and functionality. Our team also provides in vitro assay development, creating robust and reliable systems to evaluate biological responses and support research and regulatory needs. In addition, we offer mouse testing services, delivering high-quality preclinical data that bridge the gap between laboratory discoveries and clinical applications.
Medical Device Development
Our engineering team specializes in the development of complex medical devices, leveraging expertise across mechanical design, miniaturized electronics, software integration, and systems engineering. We apply rigorous design controls and risk management practices in alignment with ISO 13485, IEC 60601, and FDA 21 CFR Part 820 requirements, ensuring compliance from concept through commercialization. Our process includes detailed requirements definition, CAD modeling, simulation, rapid prototyping, and design verification and validation, supported by robust testing and documentation protocols. We bring deep expertise in miniaturized electronics, with a focus on ultra–low-power circuit design, implantable and wearable medical technologies, and compliance with EMI/EMC standards to ensure device safety and reliability. With additional capabilities in embedded systems, microfluidics, and human factors engineering, we deliver technically sound solutions that balance innovation with reliability and manufacturability.
In Vitro Assay Development
Cell-based assay services provide expertise in the design, development, and optimization of customized assays to support drug discovery, preclinical research, and product development. Capabilities include immunoassays, reporter gene assays, cytotoxicity testing, and high-content imaging. Resources and infrastructure encompass mammalian cell culture facilities, automated liquid handling systems, and advanced microscopy platforms. Tailored assay development projects are offered following in-depth consultation to align with each client’s scientific goals and technical requirements.
Animal Testing
Access to vivarium facilities with expertise to perform murine studies in both rat and mouse model systems. With animal care and use oversight provided by the CalState LA IACUC committee, research studies are performed with compliant standards.
