The testing of medical devices are a significant part of the design and manufacturing processes, and the efficacy of these stages plays a vital role in determining their usefulness. In the medical device industry, it is crucial to meticulously evaluate the quality and functionality of each component to ensure optimal performance.
It is essential to know that international regulations exist to ensure the highest quality of medical instruments used during patient interventions. In addition, these regulations promote patient safety and acknowledge the exceptional work of healthcare professionals who utilize them.
At Seisa Medical, we adhere to rigorous testing processes throughout the medical device design cycle and manufacturing. Our comprehensive testing is designed to address various issues, including composition, performance, material durability, and safety.
Test Capabilities for Medical Devices
Dimensional verification
We meticulously verify the dimensions and functionality of each device, including parameters such as length, diameter, geometry, and tolerances, to ensure optimal adaptation for its medical purpose.
Material Composition
We analyze the composition of the materials used for each component, ensuring they meet the specifications and standards for biocompatibility and durability.
Delivery, deployment, and retraction: We provide that all system components, such as tubing, connectors, valves, and pumps, meet the specified dimensional and performance requirements. This ensures proper function during the administration or delivery of treatments.
Deployment Force Testing
We evaluate the bond strength between the stent and its delivery system, ensuring secure and reliable deployment.
Biocompatibility
For prosthetics or implantable parts, we strive for compatibility with the human body’s tissues, shapes, and dimensions, ensuring the desired benefits in the targeted area.
Shelf Life
We determine a device’s durability by subjecting it to accelerated temperature, humidity, vibration, and mechanical stress conditions. This guarantees superior performance over an extended period.
Packaging tests
We inspect the packaging’s strength and integrity to guarantee the device’s protection during transportation and storage, even under extreme conditions.
Catheter bond strength
We thoroughly examine catheters to assess strength, flexibility, navigability, and stability. Additionally, we ensure there are no leaks or failures during usage.
Torque Strength
We measure the stent’s ability to withstand rotational forces during deployment.
Shape Memory and Superelasticity of Stents
We evaluate their properties to maintain their shape and flexibility during deployment and conform to the vessel walls.
Surface Area Percentages
We measure the coverage of stent struts against the vessel wall, ensuring adequate contact.
Foreshortening
We determine the extent to which the stent changes in length during deployment, ensuring accurate placement.
Mechanical Properties
Tensile strength, hardness, and elasticity, are assessed to ensure the stent meets the required mechanical performance standards.
Stress/Strain Analysis
We measure the stent’s response to stress and strain, helping to understand its behavior under different physiological conditions.
Fatigue Analysis
We examine the stent’s durability over repeated cycles of expansion and contraction, ensuring it can withstand long-term use without failure.
Accelerated Durability Testing
We subject the stent to accelerated aging conditions, simulating the long-term effects of implantation.
Particulate Evaluation
We check that the stent does not generate or release particles that could pose a risk to the patient.
MRI Safety and Compatibility
We ensure the stent’s safety for magnetic resonance imaging (MRI) without interferences.
Radiopacity
We evaluate the visibility of the stent under X-ray imaging.
Stent Integrity
We examine the stent’s structural integrity, evaluating its ability to withstand compression forces and maintain its structural integrity under physiological conditions.
Stent Corrosion Resistance
We check the stent’s resistance, ensuring its long-term durability when exposed to bodily fluids and harsh environments within the body.
Crush Resistance
We check the stent’s ability to withstand external forces without collapsing or deforming.
Kink Resistance
We examine the stent’s resistance to kinking and maintain a smooth pathway within the vessel.
Coating Integrity
We verify the integrity of the coating, ensuring it adheres correctly and remains intact during use.
Radial Stiffness and Radial Strength
We measure the stent’s resistance to radial compression and its ability to maintain luminal patency.
Radial Outward Force
We determine the stent’s ability to exert a controlled outward force against the vessel walls, aiding in vessel wall apposition.
We understand the significance of conducting internal tests to enhance our capabilities and optimize production. Moreover, we collaborate with external test laboratories to perform comprehensive evaluations, ensuring that we meet the quality requirements for medical devices. Accordingly, we act in-house as outsourced lab testing to offer highly efficient products.
Advantages of Testing Services in the Medical Device Industry
Testing capabilities are crucial in the medical device industry, ensuring that devices function effectively in real-life medical scenarios. In addition, the quality of these tests directly impacts improving a patient’s quality of life.
At Seisa, we strive to establish highly efficient testing processes that deliver optimal quality materials to healthcare facilities. Our testing services offer several significant benefits:
Regulatory Compliance
We ensure compliance with stringent quality, safety, and efficacy standards imposed by regulatory bodies.
Safety Evaluation
Our services include a thorough evaluation of the safety aspects of medical devices, ensuring their suitability for use in patients.
Performance Validation
We validate the performance of medical devices based on established specifications tailored to their specific applications.
Continuous Improvement
We are committed to designing and developing new, more efficient, reliable products that address emerging medical needs.
Our pursuit of excellence is evident in our relentless efforts to produce reliable, safe, and durable products. By prioritizing life and health in every step of our processes, we harness the benefits of rigorous testing for each component.
Testing Experience and Knowledge
We stand as industry specialists with over 35 years of extensive experience and profound knowledge in conducting precise and reliable testing procedures for manufacturing medical devices. The following standards exemplify our commitment to regulatory compliance:
- ISO 13485:2016 certification
- Expertise in manufacturing Class I, II, and III devices, including premarket approval (PMA)
- FDA registration and adherence to the Code of Federal Regulations Part 820
- ISO 7 and 8 certified cleanroom-controlled environments
- Equipped with in-house metrology labs
- Partnership with international quality testing laboratories
- We possess renowned technical capabilities for producing medical parts, utilizing cutting-edge test equipment to ensure efficient and comprehensive evaluations. Our dedication to meeting customer expectations reflects our adherence to the highest quality management system (QMS) regulations.
Test Equipment
At Seisa Medical, we possess cutting-edge testing equipment for efficient and thorough evaluations. As a result, we can conduct highly rigorous tests during the design phase of our components. Moreover, our advanced 3D development technology and project management enable us to perform pilot tests and implement continuous improvements.
Our goal is to deliver a final product that is reliable, safe, and precise in its operation. These conditions are made possible through our investment in state-of-the-art equipment and the expertise we have gained over our 35-year tenure in the industry.
Advantages of Testing Services in the Medical Device Industry
Testing capabilities are crucial in the medical device industry, ensuring that devices function effectively in real-life medical scenarios. In addition, the quality of these tests directly impacts improving a patient’s quality of life.
At Seisa, we strive to establish highly efficient testing processes that deliver optimal quality materials to healthcare facilities. Our testing services offer several significant benefits:
Regulatory Compliance
We ensure compliance with stringent quality, safety, and efficacy standards imposed by regulatory bodies.
Safety Evaluation
Our services include a thorough evaluation of the safety aspects of medical devices, ensuring their suitability for use in patients.
Performance Validation
We validate the performance of medical devices based on established specifications tailored to their specific applications.
Continuous Improvement
We are committed to designing and developing new, more efficient, reliable products that address emerging medical needs.
Our pursuit of excellence is evident in our relentless efforts to produce reliable, safe, and durable products. By prioritizing life and health in every step of our processes, we harness the benefits of rigorous testing for each component.
Seisa Medical: Value-Added Services for Clinical Trials
Seisa Medical offers a range of value-added services tailored to the needs of professionals in the medical device industry. Our commitment to delivering high-quality products sets us apart. Besides, we provide expert consultancy, regulatory support, and personalized test protocols to ensure the success of each client’s project and meet all necessary production requirements.
Our services encompass rapid prototyping, design, and project management, facilitating comprehensive testing capabilities and ensuring reliable verification and validation of medical devices. By leveraging our expertise, manufacturers can achieve higher reliability in their production processes. Moreover, our services help meet the stringent regulatory requirements of manufacturing and utilizing these medical devices.