Medical Device Safety Assessment Services
- Drug-Eluting Devices
- Grafts and Scaffolds
- Catheters and Vascular Implants
- Stents, Guide Wires, and Clot Retrievers
- Continuous Glucose Sensory Monitors
- Endoscopic and Ocular Devices
Our company is a pioneering name in the life sciences industry with over two decades of experience, standing at the forefront of providing comprehensive medical device safety assessment services. Leveraging a team of seasoned experts and state-of-the-art facilities, our company offers tailored studies aimed at evaluating potential risks associated with the use of medical devices for their intended purposes.
Medical Devices That We Can Test
Our company boasts proficiency in testing a diverse array of medical devices, encompassing various therapeutic areas and technological advancements. Some of the medical devices that our company can test include:
Drug-Eluting Devices
Grafts and Scaffolds
Catheters and Vascular Implants
Stents, Guide Wires, and Clot Retrievers
Continuous Glucose Sensory Monitors
Endoscopic and Ocular Devices
Drug-Eluting Devices
Our company conducts rigorous evaluations to assess the safety and efficacy of drug-eluting devices, ensuring optimal performance and patient safety.
Grafts and Scaffolds
Our company conducts thorough assessments to evaluate the biocompatibility, structural integrity, and performance of grafts and scaffolds, facilitating their clinical translation and regulatory approval.
Catheters and Vascular Implants
Our company conducts comprehensive safety assessments to ensure the reliability, durability, and safety of catheters and vascular implants, minimizing the risk of adverse events during clinical use.
Stents, Guide Wires, and Clot Retrievers
Our company evaluates the performance and safety of these devices through meticulous testing, enabling clinicians to make informed decisions regarding their use in clinical practice.
Continuous Glucose Sensory Monitors
Our company conducts rigorous evaluations to assess the accuracy, reliability, and safety of continuous glucose sensory monitors, empowering patients with effective tools for glycemic control.
Endoscopic and Ocular Devices
Our company conducts comprehensive evaluations to ensure the safety, efficacy, and usability of endoscopic and ocular devices, fostering advancements in minimally invasive procedures and ocular drug delivery systems.
Diagnostics and Imaging Modality Devices
Our company offers support for diagnostics and imaging modality devices, enabling comprehensive evaluation and characterization of medical products. Some of the diagnostics and imaging modality devices supported by our company include:
Fluoroscopic Radiography
Fluoroscopic radiography, facilitated by advanced imaging systems, provides real-time visualization of anatomical structures and medical devices during interventional procedures. Our company utilizes fluoroscopic radiography to assess the performance and positioning of medical devices, ensuring optimal clinical outcomes.
Ultrasound Imaging
Ultrasound imaging, including techniques such as Intra-cardiac Echocardiography (ICE) and Transthoracic Echocardiogram (TTE), offers non-invasive visualization of cardiac structures and blood flow dynamics. Our company leverages ultrasound imaging to evaluate the functionality and safety of medical devices, enabling precise localization and characterization of anatomical abnormalities.
Support for Analytical and Imaging Platforms
Our company provides comprehensive support for analytical and imaging platforms, facilitating the characterization and validation of medical devices. Some of the analytical and imaging platforms supported by our company include:
Blood Gas Measurement (iSTAT)
Blood gas measurement, facilitated by advanced analyzers such as iSTAT, allows for the assessment of oxygenation and acid-base balance in critically ill patients. Our company utilizes blood gas measurement to evaluate the physiological impact of medical devices on systemic parameters, ensuring patient safety during clinical use.
Clinical Pathology and Histopathology
Our company offers expertise in clinical pathology and histopathology, enabling detailed assessment of tissue reactions, inflammation, and healing processes associated with medical device implantation.
Biomarker Analysis
Our company conducts biomarker analysis to identify potential biomarkers associated with device-related adverse events or therapeutic efficacy, facilitating risk assessment and personalized medicine approaches.
Endoscope and Laparoscopic Unit
Our company provides support for endoscopic and laparoscopic units, enabling visualization and manipulation of medical devices within the body cavity, thereby minimizing surgical trauma and enhancing patient recovery.
Our company is a leading provider of medical device safety assessment services, offering comprehensive testing, diagnostics, and support for a wide range of medical devices. Contact us to learn more about how we can support your scientific endeavors and help you achieve your goals.
Trust Us for Your Safety Assessment Needs.
Our company offers a comprehensive range of medical device safety assessment services to support a wide range of research and development efforts in the pharmaceutical, biotechnology, materials science and chemical industries.
Please kindly note that our products and services are for research use only.
