Services

We have a team of experts with extensive experience in medical device design. We follow a fully integrated development cycle to provide optimized design control packages that meet both FDA policies and regulatory requirements.

We understand that the success of a medical device relies heavily on its design and development phase. Therefore, our team works diligently to ensure our products meet regulatory needs and market demands.

We use the latest methods and technologies in the industry to bring your ideas to life and take them from concept to completion.

Our vertical integration strategy allows us to handle everything from design to commercial approval, scale production, and maintenance. This approach reduces supply chain risks and improves efficiency.

Seisa Medical provides comprehensive regulatory and compliance solutions for medical device manufacturers, ensuring adherence to laws, regulations, and standards.

Our services include quality management systems, design controls, post-market surveillance, and clinical evidence. With a focus on patient safety and effective quality management, we help companies bring their products to market quickly and efficiently.

We also use a user-configurable workflow management platform and global data syndication hub to optimize processes, minimize inefficiencies, and improve regulatory compliance. FDA approval is necessary for selling medical devices in the US, and Seisa Medical can assist with this process.

At Seisa, we specialize in medical device prototyping to support the specific opportunities and challenges in the initial phases of medical device design development. Our rapid prototyping processes, including 3-D printers, fast mold generation, and in-house tooling abilities, allow us to produce prototypes and component samples quickly and efficiently from various materials.

We offer the best medical devices prototyping and manufacturing practices, such as proof of concept, functional prototyping, engineering validation, and pilot production. With over 40 years of experience, we provide feasibility support to ensure your idea is feasible for production. Contact us today to learn more.

Our team designs the assembly process flow to optimize manufacturability and efficiency. This includes material selection, tooling, and fixture development. We carefully select materials that meet the requirements for the product’s function and design while considering factors such as cost and environmental impact.

Our team also designs specialized tools and fixtures customized to the product’s specific requirements, ensuring accuracy and consistency in the assembly process. Optimizing the assembly process ensures that the production is efficient and cost-effective, resulting in a high-quality product for our clients and customers.

Seisa Medical offers full service of Design and Development for delivery systems, therapeutic stents, and components.

Our experienced engineering team offers rapid prototyping, finite element analysis, project management, design for manufacturability, verification, validation for clinical/pre-clinical tests, and design controls.

From basic concepts to optimized prototypes for manufacturability, we provide design solutions for delivery systems and components.

Trust us for your design needs when it comes to interventional medical devices. Our risk management approach ensures the successful validation of your products.

Trust our team of experts to help you select the best materials for your medical device manufacturing needs. We offer comprehensive material selection services, including material sourcing and full incoming inspection. Our range of materials includes a wide range of plastics processing such as Polycarbonate, ABS, Polystyrene, Polyethylene, Nylon, Acetal, etc., and other specifics such as Nitinol (NiTi), Cobalt Chromium (CoCr), Stainless steel (SS 316L, SS 316VLM), Specialty alloys (L605, Phynox, MP35N), Tantalum, platinum, and gold for therapeutic stent applications.

With our expertise, you can be sure that the materials used in your medical products meet the highest standards of quality and safety. Contact us today to learn more about our material selection services and how we can help you bring your medical devices to market with confidence.

Seisa Medical provides comprehensive testing capabilities to ensure the success of your medical device.

Our experienced team offers rapid prototyping, design, and project management services, and you can trust us for all your verification and validation needs.

Our testing capabilities include dimensional and functional testing, delivery system dimensional and functional testing, deployment testing, packaging testing, catheter testing, and shelf life testing.

With Seisa Medical, you can be confident that your medical device will meet all regulatory requirements and perform to the highest standards.

After completing the design phase, Seisa Medical can move into production. This involves process validation to ensure high-quality and consistent output, procuring materials, and scaling up for volume manufacturing to meet customer demand.

The process validation includes various tests to ensure efficiency, effectiveness, and reliability. Material procurement involves sourcing and purchasing the raw materials and components necessary for building the device. Finally, scaling up for volume manufacturing optimizes the production process for efficiency and cost-effectiveness. Completing these steps ensures that the product is manufactured efficiently, consistently, and reasonably priced.

Seisa Medical offers a thoroughly documented Collaborative Transfer Process that ensures your device is successfully transferred to our manufacturing sites in compliance with the regulatory guidelines.

During the project transfer, we perform process validation, acquire necessary materials, and scale up for volume manufacturing.

We understand that a successful product transfer is critical to the success of your medical device, and that’s why we prioritize a collaborative approach that emphasizes communication, teamwork, and transparency.

Seisa Medical provides comprehensive supply chain solutions for medical device manufacturers, ensuring efficient material management and compliance with regulations.

Our supply chain experts work closely with customers to integrate materials management into operational planning.

We offer customized solutions, including inbound and outbound logistics, vertical integration, supplier selection, and vendor management, with disciplined management of KPIs to prevent disruptions.

We track lead times, availability, prices, trends, and other variables to maximize effectiveness and maintain a lean and reliable supply chain.

Our advanced materials are delivered to the production line on time, every time. Choose Seisa Medical for optimized supply chain management and seamless medical device manufacturing.

Seisa provides comprehensive medical device manufacturing services for FDA 510K registered products. Our portfolio includes fully patented and certified products such as microcatheters, guidewires, catheters, and sheaths. We have the expertise to handle any process stage with a commitment to quality and excellence.

Our manufacturing processes undergo strict quality testing and certifications to ensure the safety and effectiveness of our medical products. We work closely with our clients to offer customized solutions that meet their requirements.