Product Development

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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

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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 510K registration documentation, and provides ongoing support through customer reviews until registration is finalized.

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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.

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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.

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Product Development Expertise

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Seisa offers completely customized solutions backed by more than 35 years of medical device experience. We leave the choices to you, bringing our team of experts and engineers to any stage of the process where you need support to build the right combination of design, prototyping, simulation, and testing solutions to meet your goals.

  • Carotid & Neurovascular Stents
  • Coronary Applications
  • Dialysis Devices
  • Orthopedic / Arthroscopic Devices
  • Neuromodulation
  • AAA/TAA Devices
  • Peripheral Stents (SFA/Popliteal, Illiac, Tibial)
  • Introducer Sets
  • Stent Delivery Systems
  • Delivery System Components & Sub-Assemblies

510K Registered Products

Seisa has developed a range of fully patented and certified products as well as the capacity to execute any stage of the process.

  • Microcatheters
  • Guidewires
  • Support Catheters
  • Guiding Sheath
  • Guiding Catheters
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