Services

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 & Development Seisa Medical

Product Design & Development

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.

Read More »
510k Approval & Regulatory Support

510k Approval & Regulatory Support

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.

Read More »
Medical Prototyping Seisa Medical

Medical Device Prototyping

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.

Read More »
pd process tooling design

Process and Tooling Design

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.

Read More »
supply chain management,ISO 13485,MDR,supply chain disruption,medical device manufacturers,supply chain risk management,agile model,wide range,development process,regulatory requirements,approval process

Design of Delivery Systems and Components

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.

Read More »
Supply Chain Solutions Seisa Medical

Material Selection

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.

Read More »
seisa testing capabilities 1

Testing Capabilities

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.

Read More »

New Product Introduction

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.

Read More »
medical device manufacturing collaborative transfer process

Collaborative Project Transfers

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.

Read More »
supply chain ratio

Supply Chain Solutions

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.

Read More »
pd 510k registered

FDA Registered Products

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.

Read More »
Product Design & Development Seisa Medical

Product Design & Development

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.

Read More »
510k Approval & Regulatory Support

510k Approval & Regulatory Support

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.

Read More »
Medical Prototyping Seisa Medical

Medical Device Prototyping

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.

Read More »
pd process tooling design

Process and Tooling Design

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.

Read More »
supply chain management,ISO 13485,MDR,supply chain disruption,medical device manufacturers,supply chain risk management,agile model,wide range,development process,regulatory requirements,approval process

Design of Delivery Systems and Components

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.

Read More »
Supply Chain Solutions Seisa Medical

Material Selection

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.

Read More »
seisa testing capabilities 1

Testing Capabilities

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.

Read More »

New Product Introduction

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.

Read More »
medical device manufacturing collaborative transfer process

Collaborative Project Transfers

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.

Read More »
supply chain ratio

Supply Chain Solutions

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.

Read More »
pd 510k registered

FDA Registered Products

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.

Read More »

Product Development Expertise

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

Case Study

Scalability

Seisa Medical was challenged to increase production output of an implantable device by 50% within just four months. Seisa’s customer — a large multinational medical device player — introduced an improved version of their Class III device to incredibly strong market demand. As a result, Seisa Medical was challenged to significantly increase production output of the implantable device while sustaining quality levels and operational KPIs. The product required a highly specialized skill set for operator certification. Historical data indicated several thousand people would need to be recruited for intensive training before final selection of the few hundred required. All this needed to be done within a four-month period.

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.

By leveraging Seisa’s customized solution, including advanced recruiting and training methods, the customer gained significant market share and increased sales on a high margin product line that is still growing.

Project Transfer

Seisa helps customer with product transfer for higher profitability. A small division of a large healthcare company approached Seisa for assistance with a portfolio of disposable products. The customer was facing profitability challenges and growing concerns related to regulatory compliance. The product mix included a variety of sterile single-use devices and the customer possessed limited experience with production transfers.

Seisa proposed a tailored solution to support the customer’s plan to drastically reduce the product mix, while bringing the product into Seisa’s established medical device assembly facility, taking over turnkey supply chain management and leveraging Seisa’s fully compliant Quality Management System (QMS). Seisa mapped the customer’s QMS and adapted a customized and fully-compliant quality plan to support the customer’s refined product portfolio. Following Seisa’s standardized transfer process, a special team lead the review of all customer requirements and built a documented transfer plan. The Seisa transfer manager conducted daily project reviews with the extended team including both Seisa and customer representatives. The cross-functional transfer team included subject matter expertise in all relevant functional areas and addressed specific manufacturing techniques for bonding, mechanical assembly, ultrasonic welding, and plastics processing.

  • The Seisa team completed the transfer plan within 4 months, 2 months ahead of plan
  • Made customer’s implantable device profitable by reducing overhead and improving inventory management
  • Alleviated customer’s quality and regulatory concerns by producing device under Seisa’s proven QMS
  • Seisa continues to deliver a high-quality product on time and at a lower cost than the customer’s previous process