Medical Device
Testing

Medical Device Testing Services

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.

  • World-Class Surgical Team led by renowned resident surgeon
  • Deep expertise in complex, minimally-invasive, and open surgical procedures for device implantation.
  • Multi-Species Large Animal Models Porcine, ovine, canine, and NHP models for the most translationally relevant anatomical and physiological environment.
  • GLP-Compliant & ISO 10993 Studies Safety studies conducted in adherence to Good Laboratory Practice (GLP) and ISO 10993 biocompatibility standards.
  • Advanced Imaging & Functional Assessment Integration of advanced imaging and functional readouts to monitor device performance and host response over time.
  • Comprehensive Pathology & Histology In-house, board-certified pathologists providing expert analysis of tissue integration, biocompatibility, and local tissue effects.
  • IDE Submission Support Data packages and comprehensive reports for Investigational Device Exemption (IDE) submissions.

World-Class Surgical Skills to Empower Implantable Device Trials

The success of any implantable medical device study hinges on the skill of the surgical team. BioLegacy’s team is led by a world-renowned veterinary surgeon making Biolegacy Research well regarded for microsurgeries and cranial implants. 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.

  • Elite Surgical Team with deep experience in implantation and unparalleled microsurgical skill.
  • State-of-the-Art Surgical Suites with integrated and real-time hemodynamic monitoring.
  • Complex & Microsurgical Capabilities Proficiency in challenging procedures, including minimally-invasive and interventional techniques.
  • Dedicated Anesthesiology & Post-Op Care Comprehensive peri-operative and post-operative support to ensure animal welfare and data integrity.

Species Selection to Ensure Translational Relevance

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.

  • Comprehensive Species Portfolio Expertise with rodents, rabbits, canines, swine, sheep, and non-human primates. Other species available upon request.
  • AAALAC-Accredited Vivarium We maintain the highest global standards for animal welfare.
  • Specialized Husbandry Programs Tailored environmental enrichment and care protocols for the unique needs of each species.
  • Dedicated Veterinary & Technical Staff On-site, board-certified veterinarians and AALAS-certified technicians.

Submit Your IDE Quickly & Confidently

Let BioLegacy’s Medical Device team guide you.

  • Species / model selection for optimal translational relevance
  • Best-of-class surgical capabilities
  • New, state-of-the-art facilities
  • Rapid study initiation & accelerated reporting
  • GLP & ISO compliant to streamline global regulatory submissions
Need a unique model? Contact us today.