Medical
The Medical division provides engineering design and product development support for orthopedic and implantable medical devices intended to assist in bone stabilization and accelerate healing. Work within this sector emphasizes design precision, regulatory alignment, and compliance with FDA 510(k) premarket clearance pathways, supporting clients in bringing safe and effective solutions to market.
Experience includes the development of orthopedic constructs engineered to support skeletal stabilization and functional restoration across the human body. Designs incorporate advanced surface modeling techniques, analytical validation, and biocompatible material choices to achieve optimal performance, reliability, and manufacturability.
Projects often involve collaboration with regulatory specialists to identify appropriate predicate devices, ensuring the new design demonstrates substantial equivalence in intended use, technological characteristics, and overall safety and effectiveness. By referencing legally marketed, FDA-cleared devices, the team helps streamline the submission process and reduce potential challenges associated with outdated technologies or reclassification requirements.
Using SolidWorks for 3D CAD modeling and Finite Element Analysis (FEA) for structural evaluation, design iterations are informed by both engineering insight and regulatory best practices. This combination allows for efficient design verification and documentation aligned with the expectations of the Federal Food, Drug, and Cosmetic Act.
Throughout each engagement, the focus remains on adaptability, traceability, and compliance, enabling clients to progress confidently from concept development to regulatory submission.
Whether supporting early-stage feasibility, prototype refinement, or full-scale validation, the medical division provides methodical, data-driven engineering support that strengthens the path to market readiness.