The successful progression of a novel medical device from concept to clinical use requires preclinical data that demonstrates both safety and functional performance in a clinically relevant setting. At BioLegacy, our medical device testing services are built upon a foundation of unmatched surgical expertise, deep regulatory insight, and the most translational animal models. Our world-class veterinary surgeons operate in state-of-the-art surgical suites, specializing in the complex implantation and evaluation of a wide range of devices. This surgical precision, combined with our expertise in large animal models that mimic human anatomy and physiology, ensures the generation of robust data to de-risk your device and facilitate a successful IDE submission.
The success of any implantable medical device study hinges on the skill of the surgical team. BioLegacy’s team is led by Dr. DingGang Liu, a world-renowned veterinary surgeon known especially for his skill at microsurgeries. Operating in state-of-the-art surgical suites equipped with advanced imaging and monitoring technology, our team ensures optimal device placement, even in small animal models. This surgical excellence delivers the most reliable data on your device’s safety and performance.
The translational relevance of your medical device’s preclinical data is wholly dependent on using the most appropriate animal model to recapitulate human physiology in your study. BioLegacy’s range of species, from rodents and rabbits to large animals including canines, swine, sheep, and non-human primates, provides the ultimate flexibility to meet this need, and our experts will guide you to the most scientifically sound model for your medical device.
All our animals are housed in a state-of-the-art, AAALAC-accredited vivarium where our husbandry and veterinary teams ensure the highest standards of animal welfare and the generation of reliable, reproducible data.
BioLegacy is equipped to conduct safety and performance studies for virtually any class of medical device. Our multidisciplinary teams of surgeons, scientists, and pathologists have deep experience across a broad spectrum of device modalities, from complex cardiovascular implants to novel neurostimulation leads. We tailor each study to the specific design, intended use, and regulatory pathway of your device, ensuring we generate the precise, relevant, translational data required for IDE submission.
Let BioLegacy’s Medical Device team guide you.