Medical Device Testing

Medical Device Testing

Overview Service

At our Medical Device Testing division, we are dedicated to providing comprehensive testing services for all classes of medical devices. Our state-of-the-art laboratory is equipped with the latest equipment and facilities necessary to conduct a wide range of regulatory tests such as bio-compatibility, hemo-compatibility, reprocessing studies, sterilization studies, and more.

Our team of experienced professionals has the expertise to conduct all necessary regulatory tests for medical devices, ensuring that they meet the necessary regulatory requirements for distribution. Our speciality lies in conducting reprocessing and revalidation studies for medical devices, making us one of the few labs with such capabilities.

We are also capable of conducting functional testing and xenograft testing, which helps us to understand the performance and safety of medical devices in real-world scenarios.

At our Medical Device Testing division, we offer a wide range of testing services for medical devices, including extractable and leachable studies. These studies are critical for understanding the potential interactions between medical devices and biological tissues, ensuring that the devices are safe and effective for use in clinical settings. Our team of experienced professionals has the expertise to design and conduct extractable and leachable studies to meet the specific needs of our clients, ultimately ensuring the safety and efficacy of their medical devices..

All our testing is conducted as per standard guidelines, including ISO, FDA, and other international standards. We ensure that our testing services are in compliance with the necessary regulatory requirements, providing our clients with the confidence that their products will meet all necessary standards for distribution

Our mission is to provide comprehensive testing services that ensure the safety and efficacy of medical devices. We invite you to explore our website to learn more about our research, facilities, and expertise. Please feel free to contact us for any medical device testing you may require.

Our Lab

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Quick overview of services we can provide

Biocompatibility Testing

• Cytotoxicity testing
• Sensitization testing
• Irritation and intracutaneous reactivity testing
• Systemic toxicity testing
• Genotoxicity testing
• Implantation testing ( Rodents, Rabbits, Mini-Pigs etc)

Sterility Testing

• Sterility assurance testing
• Microbial limits testing
• Bacterial endotoxin testing
• Bioburden determination
• Sterilization process validation

Shelf-Life Determination

• Accelerated aging studies
• Stability testing
• Package integrity testing
• Material degradation analysis
• Environmental testing (temperature, humidity)

Mechanical Testing and Performance Evaluation

• Tensile strength and elongation testing
• Compression testing
• Flexibility and fatigue testing
• Wear and friction testing
• Load and stress testing
• Biomechanical testing

Packaging and Labeling Evaluation

• Package integrity testing
• Labeling verification and validation
• Shelf-life assessment of packaged products
• Environmental impact analysis (recyclability, sustainability)