In healthcare, the importance of medical devices cannot be overstated. These instruments play a crucial role in diagnosing and treating diseases to save the patients life; they are manufactured with meticulous attention to quality.
The manufacturing process of medical devices is highly specialized, requiring technical expertise and great attention to detail. Therefore, this intricate process must be entrusted to experienced professionals who understand the complexities and adhere to the industry’s strict regulations.
At Seisa Medical, we have been at the forefront of medical device manufacturing for over four decades. We have established ourselves in producing Class II and Class III medical devices. Our unwavering commitment to excellence is demonstrated by our strict compliance with numerous regulations set by authorized bodies, including the FDA in the United States.
We possess the expertise, regulatory knowledge, and unwavering commitment to deliver the highest quality medical devices.
From Concept to Creation: Discover Seisa's Unmatched Medical Device Manufacturing Services
At Seisa, we are committed to excellence, providing top-tier manufacturing services to deliver reliable, high-quality medical devices. Our full assembly cycle ensures adherence to the highest manufacturing standards for clinical equipment, following an integrated process that includes:
Design Transfer
We begin by evaluating market needs and collaborating with clients to refine the device’s design based on valuable feedback. Once validated, the plan is seamlessly transferred to our manufacturing department.
Design Iteration
Engaging with healthcare professionals and stakeholders, we continually assess market reception and make design improvements to enhance performance and usability.
Design Engineering
Employing cutting-edge practices, our skilled design team translates consumer needs into precise specifications, ensuring the device meets rigorous safety, effectiveness, and regulatory benchmarks.
Design Verification
Following design completion, we meticulously ensure compliance with health regulations through comprehensive testing and validation, including functionality and durability assessments.
Production
Utilizing state-of-the-art machinery and manufacturing techniques, we adhere to strict quality control measures, conducting inspections and tests throughout the show to guarantee each device’s reliability and safety.
Advantages of working with Seisa
ISO 13485:2016 Certified Teams
Seisa’s certification in ISO 13485:2016 reflects our commitment to adhering to quality standards, ensuring that our manufacturing processes consistently produce medical devices meeting customer and regulatory requirements.
FDA Regulatory Compliance
We implement systems and solutions that are fully compliant with FDA regulations, ensuring that our products meet stringent standards for safety and effectiveness in patient care.
Cost-Efficient Manufacturing
Through optimization of manufacturing processes, material waste reduction, streamlined labor, and advanced technologies, Seisa offers competitive pricing without compromising quality.
Loss Minimization
Leveraging lean manufacturing principles, we reduce errors and enhance product quality through continuous monitoring and process optimization.
Class 7 and 8 Cleanroom Certifications
Seisa’s cleanroom certifications represent our commitment to excellence, indicating that our facilities meet the rigorous standards necessary to minimize particulates and avoid contamination, which is vital for the safety and performance of medical devices.
Experience and Expertise in Medical Device Manufacturing
Seisa, with over 40 years of experience, is a trusted leader in the medical device manufacturing industry. Our expertise encompasses regulatory compliance, quality control, and efficient production processes.
Our Services
Class II and Class III Medical Devices
We specialize in manufacturing Class II and III medical devices with stringent adherence to safety, efficacy, and regulatory standards.
Cardiac Implants
We produce high-precision cardiac implants that prioritize durability and patient safety by utilizing advanced manufacturing capabilities.
Tube Sets
We excel in producing reliable tube sets compatible with various medical applications, adhering to strict quality control measures.
Pediatric Products
Our range of pediatric medical devices caters to the unique needs of children, ensuring exceptional quality and safety.
Specialized Support
Beyond manufacturing, we offer specialized support in device design, refinement, production, and marketing for a comprehensive product launch.
Seisa is committed to delivering high-quality medical devices through optimized manufacturing processes focusing on efficiency and excellence. We leverage state-of-the-art technologies and rigorous quality control measures—partner with Seisa to bring innovative and reliable medical devices to the market.
Overview of Medical Device Manufacturing
Seisa Medical manufactures high-quality medical devices for surgical procedures, diagnosis, and treatment. Leveraging advanced manufacturing technologies and adhering to regulatory standards, we produce reliable and safe devices essential for patient care.
Our Product Range
- Endoscopy Equipment: Minimally invasive procedures for organ visualization and interventions.
- Automated Medication Dispensing Systems: Enhancing patient safety with accurate and efficient medication management.
- Heart Valves: Essential for treating heart valve diseases and restoring cardiac function.
- PTA Balloon catheters: Unblock blood vessels and improve peripheral artery blood flow.
- Steerable catheters: Precise control and maneuverability for accessing hard-to-reach areas.
- Urology catheters: Drainage or fluid delivery in urological conditions.
- Microcatheters: Delicate procedures, accessing small blood vessels or targeted medication delivery.
- Guidewires: Accurate placement and navigation in blood vessels or body cavities.
- Delivery catheters: Transport and deploy medical devices to targeted locations.
- Customized solutions: Tailored designs for specific medical requirements and optimal outcomes.
Equipment and tools
Injection molding allows the production of articles in large quantities. It improves the work capabilities of the devices. To enhance the quality of our services, laser welding tools increase the value of this equipment. The advanced machinery used by Seisa Medical allows thorough cleaning in clean rooms.
Our work team has developed injection molding as one of the most significant productions. Additionally, we designed a practical guide to manufacture molds and materials with optimum efficiency. To improve the quality, we incorporate a first-rate metal processing method.
What sets Seisa medical device manufacturing apart?
At Seisa Medical, our distinction lies in integrating supplementary services that assure the production of superior medical devices.
A notable aspect of our process is the implementation of plastic prototypes, which are invaluable in eliminating uncertainties and optimizing production efficiency for large-scale manufacturing.
Additionally, our products are subjected to stringent testing, including component sterilization, to ensure the utmost efficacy and compliance with the highest industry standards. Our meticulous attention to detail and commitment to excellence solidify Seisa Medical as a trusted partner in medical device manufacturing.
Please get in touch with us for further information or to discuss how Seisa Medical can assist in your next project.
Medical Device Manufacturing FAQ
Q. What are medical devices?
A. The part’s geometry, the number of parts needed, the tooling budget, and the application part used will influence the decision to inject mold the characteristics.
Q. What are clean rooms?
A. Clean rooms are controlled environments with low levels of pollutants such as dust, airborne microbes, aerosol particles, and chemical vapors. They are essential in medical device manufacturing to prevent contamination.
Q. What is the ISO 13485:2016 standard?
A. ISO 13485:2016 is an internationally recognized standard that specifies requirements for a quality management system where an organization must demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.
Q. What rules and regulations must medical device manufacturers fulfill?
A. Medical device manufacturers must adhere to several standards and regulations, including ISO 13485, the Medical Device Regulation (MDRand the FDA’s 21st Century Cures Act, among others. These regulations ensure the safety, quality, and efficacy of medical devices.
Q. What advantages come with collaborating with a skilled manufacturer of medical devices?
A. Partnering with a skilled manufacturer ensures efficient production cycles, increased product quality, and potentially more significant profit margins. Such manufacturers also typically have extensive knowledge of regulatory requirements, which can expedite product approval processes.
Q. How are the safety and quality of medical devices ensured during manufacturing?
A. Safety and quality of medical devices are ensured through strict adherence to manufacturing guidelines and standards, rigorous testing, and quality control measures. This guarantees that the devices are safe for use and function as intended.
Q. What additional services are medical device manufacturers offering to ensure product quality and efficacy?
A. Besides manufacturing, services can include design assistance, regulatory consultation, product testing, and validation. For example, Seisa Medical also protects the intellectual property of medical equipment, adding a layer of security for innovators in the industry.