An ISO9001 Certified Supplier of Pre-Clinical Contract Research Service and Analytical Service
Medical devices play a crucial role in modern healthcare by aiding in the diagnosis, treatment, and monitoring of various medical conditions. Ensuring the safety, efficacy, and quality of these devices is paramount to protecting patient well-being. This is where Protheragen-ING Lab's medical device services come into play.
We specialize in providing comprehensive medical device services to help you bring safe and effective healthcare solutions to the market. Our team has extensive knowledge and experience in the medical device industry, ensuring that your devices meet regulatory standards and undergo rigorous testing and validation processes.
We Know Medical Devices
Medical devices range from simple tools such as thermometers and blood pressure monitors to complex devices such as pacemakers, imaging systems and robotic surgical systems. They can be categorized into different classes based on their intended use and potential risks.
Regulatory authorities, such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), have established guidelines and regulations to ensure the safety, effectiveness, and quality of medical devices.
Protheragen-ING Lab is supporting medical device companies around the world. We understand the principles of medical devices and their regulatory requirements. Most importantly, we know how to apply risk analysis to your products and apply the results to provide fast, cost-effective design validation and verification services.
You will benefit from this inside knowledge, gained through extensive testing experience with all classes of devices and many applications.
Find out more about each of our services
Protheragen-ING Lab offers a range of medical device services to support your product development journey. We work closely with you to understand your unique needs and provide customized solutions to meet them.
This service involves a series of rigorous evaluations to ensure that medical devices meet strict safety standards. One important aspect is bacterial endotoxin testing (BET), which evaluates the presence and concentration of endotoxins in medical devices, especially those that come into contact with blood or other sterile areas.
This service focuses on evaluating the compatibility of medical devices with living tissues and biological systems, and is designed to determine the likelihood of adverse reactions, such as inflammation or toxicity, when the device interacts with the body.
Antimicrobial efficacy testing is a key aspect of assessing the ability of a medical device to inhibit the growth of microorganisms, thereby reducing the risk of infection. In addition, for reusable medical devices, specific tests are performed to ensure that they can withstand reuse and cleaning processes without compromising their safety or functionality.
Validation involves evaluating a device's performance under real-world conditions to ensure it consistently delivers the desired clinical results. Verification, on the other hand, focuses on evaluating whether the device meets predetermined design and manufacturing requirements. We provide design validation and process verification for medical devices.
This testing service is a service that helps evaluate the safety, effectiveness, and compliance of reusable medical devices. Reusable medical devices are those that can be reprocessed and used multiple times, such as surgical instruments, endoscopes, and catheters. Services typically involve a combination of laboratory testing, performance testing, and regulatory compliance testing.
Contact us today to discuss how our services can support your specific requirements and contribute to your success in the pharmaceutical market.