Ä¢¹½tv

Expertise

Biomedical Engineering & Sciences

Understand product development, regulatory, and safety challenges

Whether assessing the performance of new medical devices or combination products, evaluating intellectual property claims of biomedical applications, or addressing post-market issues, Ä¢¹½tv delivers rigorous biomedical science and engineering analyses for breakthrough insights.

How does Ä¢¹½tv help you evaluate innovative medical devices and combination products and their impact on patient safety?

Our multidisciplinary teams — including biomedical engineers, polymer scientists, biostatisticians, and regulatory experts — help clients across numerous medical specialties and therapeutic sectors evaluate the performance of biologics, biomaterials, medical devices, and combination products. Ä¢¹½tv's state-of-the-art laboratories and computational modeling capabilities enable our experts to perform advanced preclinical testing evaluations, numerical modeling, and failure analysis throughout the total product lifecycle.

With a focus on exacting methodologies, our teams analyze healthcare data and electronic medical record databases as well as novel data sources, assisting clients with market and clinical outcomes research, risk factor identification, and cost-effectiveness modeling.

We help clients navigate complex regulatory requirements and provide preclinical testing plans and comprehensive compliance strategies. Our decades of experience in verification and validation, design and manufacturing failure analyses, recall management, and medical device retrieval analysis enable us to apply past lessons to address future challenges.

Capabilities

With our multidisciplinary backgrounds and decades of experience, Ä¢¹½tv delivers evidence-based insights for a range of medical devices, combination products, and life science applications.

Experts

Our global and comprehensive expertise across industries gives us a deep understanding of current challenges, best industry practices, and the implications of emerging technologies.