End-to-end services,
tailored solutions
We leave the choices up to you by bringing our team of experts and engineers to any stage of the process where you need support.
Product Design Services
Product Design and
Development
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.
510K Generation
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.
Prototyping
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.
Seisa created a customized solution, including investment to accelerate its recruiting cycle while leveraging an existing, robust training process. A cross-functional team was formed with Seisa’s customer to define project deliverables such as headcount, training, and layout configuration changes in compliance with regulatory requirements. The solution was supported with a milestone-based tracker with specific tasks and timelines to accomplish the required increase with no delays and without compromising quality or delivery. Using historical training data, Seisa implemented a plan to recruit and compensate more than 5,000 people to undergo Seisa’s rigorous training and certification program. Ultimately Seisa was successful in yielding the several hundred highly skilled operators needed to support the increased output requirements. Seisa’s success resulted from its robust recruiting and training practices, its investment in its people, and its experience in manufacturing Class III products.
