Nihon Bioresearch
Japanese preclinical CRO offering GLP safety and efficacy studies for drugs, devices and regenerative products, with long minipig experience.
About Medical Device Testing
Preclinical device studies show that an implant or instrument performs as intended and is safe in a living system before it is used in people. They range from acute surgical feasibility work to chronic GLP safety studies lasting months, and usually sit alongside ISO 10993 biocompatibility testing such as implantation (ISO 10993-6) and systemic toxicity (ISO 10993-11).
Unlike drug studies, device studies depend heavily on the surgeon. The model has to accept a human-scale device and the procedure has to resemble the clinical approach, so large animals are common: sheep for orthopedic and spine work, pigs for cardiovascular and many soft-tissue devices, and rabbits for implantation and some spine models, such as intradiscal and epidural studies. In-life imaging, explant handling and hard-tissue histology (undecalcified, resin-embedded sections of the bone–implant interface) each need specific expertise.
Our team has hands-on surgical experience in orthopedic spine models, including intradiscal and epidural implant studies in rabbits and sheep, and we use it when reviewing device-focused labs. Ask early how the study maps to the regulatory pathway for your device, since that shapes the endpoints and whether GLP is required.
Preclinical Medical Device Testing CROs
Showing 15 CROs. Order rotates daily so no lab is permanently listed first.
Jesus Uson Minimally Invasive Surgery Centre (CCMIJU)
Spanish translational research center offering GLP and non-GLP large animal studies, device validation, advanced imaging and surgical training.
T3 Labs
Translational testing and training laboratory in metro Atlanta supporting large animal preclinical device research, surgical models and procedural training.
Wake Forest Preclinical Translational Services
Academic preclinical service group offering GLP-compliant surgical suites, large animal housing and veterinary surgical support for device and therapeutic studies.
BSL Bioservice
Munich-area contract laboratory providing GLP toxicology, genetic toxicology, biocompatibility and microbiology testing for pharmaceutical, chemical and medical device sponsors.
DT&CRO
Korean CRO covering GLP toxicity, PK and efficacy studies through to clinical trials for drugs, devices and other products.
Bridge PTS
Preclinical research company specializing in wound healing, biofilm and infection models for drugs and medical devices, including custom surgical models and electron microscopy.
Biomere
Biomere (a JOINN company) is a preclinical CRO based in Worcester, MA. Services include non-GLP PK/PD, discovery toxicology, surgical services, disease models, and laboratory sciences. Surgical services include…
GLPigs
Hospital-based preclinical research unit in Israel offering GLP and non-GLP large animal studies, catheterization and cardiovascular device models.
NAMSA
Medical device focused CRO covering biocompatibility, preclinical surgical and interventional research, histopathology and regulatory consulting. Its Minneapolis preclinical site (formerly American Preclinical Services)…
Medanex Clinic
Belgian CRO for preclinical surgical studies and surgical training in large animals, with operating theatres, ICU and fluoroscopy.
Lahav CRO
Israeli large animal CRO offering GLP and non-GLP surgical, interventional and imaging-supported studies for devices and therapeutics.
CVPath Institute
Cardiovascular pathology research institute providing GLP pathology evaluation of stents, valves and other vascular devices in preclinical studies.
Bioneeds
OECD GLP-certified preclinical CRO near Bengaluru providing regulatory toxicology for pharmaceuticals, biologics, devices and chemicals.
AO Research Institute Davos
Musculoskeletal research institute performing preclinical orthopedic and trauma studies, including large animal bone and implant models, for industry partners.
Questions to ask when choosing a Medical Device Testing CRO
- Which species and surgical approach do you propose, and how closely does it match the clinical procedure?
- Who performs the surgery, and how many procedures of this type have they done?
- Are your implantation studies run to ISO 10993-6, and is the study GLP?
- Can you image the device in life (fluoroscopy, CT, MRI or ultrasound), and is that in the quote?
- Do you have in-house hard-tissue histology for undecalcified bone and implant sections?