Seisa Medical - Productos

Whether you need assistance with design, 510K generation, or a finished device, Seisa has your solution. Seisa supports and creates FDA 510K registration documentation, and provides ongoing support through customer reviews until registration is finalized.

With quick turnaround processes for rapid prototyping including 3-D printers, rapid mold generation, and in-house tooling capabilities, Seisa is able to produce prototypes and medical device and component samples quickly and efficiently from a variety of materials for rigorous and reliable in house testing

Bringing a complete portfolio of design, prototyping, simulation, and testing under one single roof, our fully integrated development cycle enables us to offer an optimized design control package in line with FDA guidance for medical device design and development for components and assemblies. Our design and development engineers take your idea from concept to completion, incorporating the most sophisticated techniques and technologies in the medical device industry. We lead reviews, hazard identification, and risk analysis diligently throughout our documented process.