Ä¢¹½tv

Capabilities

• Biocompatibility & Biological Risk Assessment

  Ä¢¹½tv has decades of experience and a wide range of biological assessment expertise to help you overcome biocompatibility challenges throughout the medical-device product lifecycle.

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• Wear & Biotribology

  Understanding the wear and tribological performance of medical devices and the materials used in their design is a critical part of the development process. Ä¢¹½tv has extensive experience conducting medical device wear testing, establishing wear test programs, and providing insights for clients to achieve regulatory requirements.

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• Finite Element Analysis for Medical Devices & Biomaterials

  Ä¢¹½tv combines expertise in FEA with our long-standing expertise in mechanical engineering, metallurgy, polymer science, and failure analysis to provide clients with a unique perspective for addressing complex computational projects required in the medical device industry.

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• Retrieved Device & Tissue Analysis

  Analyzing retrieved implants, tools, and tissues is essential to understanding how a medical device functions, as it provides unique in vivo insights on device mechanics, kinematics, and material performance. Ä¢¹½tv provides comprehensive retrieved device and tissue analysis to support medical device development, clinical studies, and post-market surveillance.

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• Medical Device Corrosion

  Ä¢¹½tv performs fatigue and corrosion testing for medical device companies to assist with product development, quality assurance, regulatory submissions, and post-market surveillance.

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• Biofluid Dynamics for Biomedical Devices & Products

  Understanding and predicting fluid behavior and transport has become a differentiated advantage, providing valuable insights for medical device, pharmaceutical, and biologics companies. Ä¢¹½tv delivers expert biofluid dynamics analysis using state-of-the-art model definition and software for biomedical and life sciences product development.

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• MRI Compatibility

  For millions of patients with implanted medical devices such as pacemakers, neurostimulators, and stents, magnetic resonance imaging (MRI) can pose serious risks. Ä¢¹½tv provides experienced MRI compatibility testing for medical devices to help ensure that MRI risks are mitigated and regulatory requirements are met.

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• Electrical Safety & Compliance

  Ä¢¹½tv's multidisciplinary teams help you navigate evolving regulatory requirements and applicable standards for assessing device safety, including potential electrical device hazards and risks, and risks related to batteries.

• Clinical Studies

  Procuring data sets of clinically diagnosed patients is crucial for developing medical devices and consumer health wearables, such as smartwatches and fitness trackers, and improving the accuracy of underlying algorithms. Ä¢¹½tv provides comprehensive clinical study consulting for clients, ranging from assisting with clinical study design and executing data analysis strategies to identifying clinical partners for participant recruitment and preparing documents for internal review boards or regulatory submissions.