What tools does Ä¢¹½tv have to help you develop and implement a comprehensive strategy for product development?
Ä¢¹½tv's state-of-the-art laboratories offer advanced biomedical and life sciences testing capabilities, helping you understand and address your most critical product challenges. Our biomedical engineering laboratory facilities and experienced experts can support diverse technical needs, including:
- MRI safety
- Biomaterial tribology and device wear testing
- Biocompatibility
- Multi-scale mechanical testing
- Analytical chemistry
- Microbiology and molecular biology
- Device efficacy
- Usability
Our consultants form bespoke teams bringing focused expertise to all parts of the product lifecycle, specifically matched to the depth, breadth, and capacity of your challenge. That includes thoroughly understanding your product's precise characteristics, composition, and function to help evaluate risks and performance, whether developing a customized verification and validation plan to advance its development or investigating an unexpected failure mode.
North American laboratory presence
The primary capabilities in our Philadelphia laboratory facility include biotribology, MRI safety, and mechanical characterization of engineering materials, biological tissues, and devices, as well as human factors assessments for devices and clinical procedures. Our Menlo Park, California, facility specializes in analytical chemistry testing services, device inspections, corrosion testing, and customized test setups. Both facilities are accredited to and fully compliant with 21 CFR Part 58, Food and Drug Administration Good Laboratory Practice for Nonclinical Laboratory Studies.
Ä¢¹½tv's Natick, Massachusetts, laboratory offers life sciences and biotechnology investigation capabilities, including microbiology and molecular biology, electrochemistry, optics, materials and corrosion, and bespoke mechanical and electrical characterization of medical devices, as well as fluid dynamic modeling and methods. Our Los Angeles laboratory also offers health sciences, materials and corrosion, and human factors analyses and services, and our Phoenix facilities support specialized expertise in usability studies through Ä¢¹½tv UX. All of these facilities feature extensive microscopy facilities, inspection capability, and the ability to host clients to observe testing.
Global support
Ä¢¹½tv leverages our extensive medical device industry experience and thorough knowledge of EU Medical Device Regulation requirements to support development, augmentation, and audits of documentation for technical files for risk management, clinical evaluations, and postmarket surveillance. Our lab in London provides state-of-the-art materials analysis.
Capabilities
Ä¢¹½tv's Biomedical Engineering Laboratories are equipped to provide expert services for a variety of applications.
Our Capabilities Are Unparalleled
With expertise in over 90 disciplines and hundreds of capabilities, tools, and methodologies — we get to the root of even the most complex challenges and give you the objective answers you need.
Life Sciences Due Diligence
Due diligence technical consulting services to help verify the science and technology behind medical devices and related therapeutics.
Medical Device Evaluation
Sophisticated medical device evaluations for a vast array of applications.
Medical Device Design & Development Support
Crucial medical device design and development analyses to empower your decision-making.
Biomedical Expertise for Therapeutic Areas
Multidisciplinary insights for a range of therapeutic product development challenges.
Regulatory Compliance for Medical Products
Experienced regulatory support for medical devices, pharmaceuticals, and combination products.
Biomedical Expertise for Disputes
Support for complex disputes, from intellectual property and patent infringement to hospital fires and product damage.