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Home > Project Execution > Project Expertise
Medical Device ExpertiseOur breadth of experience and product knowledge in the medical device industry makes us a unique fit and valuable partner to any OEM or contract supplier in Southern California.
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Broad Expertise, Deep Impact
Our Medical Device ExpertiseWe work across Class I, II, and III medical devices, including implants, disposables, instrumentation, and more. From simple tools to complex systems, our technical and regulatory understanding move products along effectively. |
Contract Manufacturing, Design, & ServicesWe take a collaborative approach to projects, with expertise in R&D, quality, regulatory, and testing services. Our network includes trusted contract manufacturers and niche design studios equipped to support every phase of product development. |
Our Project Expertise
Product DevelopmentWe support end-to-end design with expertise in SolidWorks, Pro-E, and CATIA, along with drafting, design library maintenance, and material selection. Our team drives product verification, environmental testing, d/pFMEA, and FEA to ensure quality, reliability, and compliance.
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Manufacturing ExpertiseWe optimize manufacturing through process improvements, Kaizen events, and design. Our support includes equipment verification, supplier and internal audits, facility layout and transfer, and product commercialization. We also lead CAPA and NCR work to ensure compliant, efficient operations. |
Quality AssuranceWe support end-to-end quality efforts, including product, process, and equipment verification and validation. Our team leads quality system development, risk management, tech transfer, and CAPA/NCR resolution, with specialized expertise in 483 remediation and regulatory compliance. |
Regulatory ComplianceWe guide teams through complex regulatory pathways, including EU MDR/IVDR transitions, 510(k), PMA, and CE Mark submissions. Our support spans compliance strategy, quality system development, 483 remediation, and specialized documentation like DO-160 for aerospace and related industries. |
Embedded SystemsWe develop embedded solutions for safety-critical devices, with expertise in RTOS, Linux, Windows applications, and mobile platforms like iOS, Android, and wearables. Our work includes cloud-based data collection, remote diagnostics, and advanced test systems—all built to meet FDA and IEC 62304 compliance standards. |
Technical Operations SupportWe provide hands-on support across documentation and knowledge transfer, including document control, technical writing, and IP handoff. We also support R&D, manufacturing, and inspection technicians, helping preserve and transfer critical tribal knowledge throughout the product lifecycle. |
Support for Medical Device Development
We provide support for medical device needs in R&D, RAQA, and Manufacturing Engineering. Click the icons below to learn more.
