Product Design Services
Product Design and
Bringing design, prototyping, simulation, and testing under one roof, fully integrated development enables us to offer an optimized design control package in line with FDA guidance. Our engineers take your idea from concept to completion, incorporating the most sophisticated techniques in the industry. We lead reviews, hazard identification, and risk analysis throughout the process.
Whether you need assistance with design, 510K generation, or a finished device, Seisa has your solution. Seisa supports and creates 510K registration documentation, and provides ongoing support through customer reviews until registration is finalized.
With 3-D printers, rapid mold generation, and in-house tooling capabilities, Seisa can produce samples quickly and efficiently from a variety of materials for rigorous and reliable testing.
Process and Tooling Design
We design the assembly process, including material selection, tooling, and fixture development, to optimize for manufacturability and efficiency.
New Product Introduction
Upon design completion, we move your device into production, performing process validation, procuring materials, and scaling up for volume manufacturing.
Testing and Sterilization
Prototypes can be subjected to dimensional analysis, surface coefficient of friction, burst, simulated use and other assessments within our laboratories. Our network includes sterilization management services, bringing your product from prototype to fully functional.