Medical device development requires a profound understanding of both electronics and the specific standards set by regulatory bodies. At Marcus Engineering, we’ve consistently demonstrated our expertise in these areas.

Working alongside clients, we aid in defining requirements, ensuring the user experience aligns with safety considerations, and simultaneously developing a technical construction file that meets FDA requirements. Whether dealing with Premarket Notification (510k), Premarket Approval (PMA), or De Novo applications for Class 1, 2, or 3 devices, our guidance ensures alignment with regulatory expectations.

The pathway from design to prototype and then to delivery for medical devices is distinctly rigorous. It mandates a stringent adherence to FDA standards, far beyond traditional engineering processes. This adherence specifically calls for maintaining traceability between customer specifications and design results.