Safety and Efficacy Models from a Dedicated Medical Device CRO
Our two state-of-the-art facilities in North America fully support your preclinical medical device testing programs in compliance with regulatory agencies. A comprehensive portfolio of safety and efficacy services includes imaging modalities and diverse histological endpoints that are quantitatively assessed using manual and software-guided automated histomorphometry. Our staff includes dedicated veterinary pathologists who can perform a full histopathological analysis and create resulting quantitative reports.
With hundreds of programs under our belt and a global network of specialized scientists a phone call away, we can advise on the optimal path to market and resolve any issues that may arise. We’ll collaborate with you to assess the unique needs of each device and establish the best plan for achieving regulatory approval quickly and on budget.
Cardiovascular Models for Medical Devices
Trust the expert guidance of a team of study directors, veterinary cardiologists, and pathologists seasoned in the conduct of sophisticated cardiovascular preclinical medical device testing programs.
Orthopedic Models for Medical Devices
We offer preclinical medical device testing services for your orthopedic program from the proof-of-concept to safety regulatory testing under GLP.
Additional Preclinical Medical Device Testing Support Services
- ENT - sinus implants drug delivery | bioresorbable stent
- Ocular - enucleation, evisceration | orbital implants
- subcutaneous; dermal filler
- wound healing; hydrogel and wound dressing
- CNS - shunts
- colon stents
- intestinal clips
- Regenerative medicine – Our wide selection of animal models allows you to evaluate growth factor therapy, tissue engineering, and cell therapy in vivo.
Frequently Asked Questions (FAQs) about Preclinical Medical Device Testing
What is a Medical Device?
A medical device is any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material, or related article intended by the manufacturer to be used in human beings, alone or in combination, for one or more of the specific purpose(s): diagnosis, prevention, monitoring, treatment or alleviation of disease or an injury, investigation, replacement, modification, or support of the anatomy or of a physiological process, supporting or sustaining life, or control of conception.
How can a medical device CRO improve my preclinical medical device study plan?
Every device is different, and there is no “one size fits all” study plan. Having seen a vast array of medical device types under development, the multidisciplinary team of experts at Charles River uses their deep understanding of efficacy, safety, and regulatory guidelines to develop an appropriate testing strategy to suit the needs of your device. Our unique combination of regulatory expertise with medical devices and comprehensive portfolio of services allows us to create a tailored plan to carry you from the earliest stages of study design to GLP assessments, so you can get you to market faster.
How is Charles River different from other preclinical medical device testing CROs?
Meeting the needs of patients with cardiovascular, orthopedic, dermatology, oncology & immuno-oncology, endocrinology, neuroscience, ophthalmology conditions and more, medical devices serve numerous therapeutic areas. As a global CRO with over 2,000 scientists, Charles River has experts in every field who partner with our dedicated medical devices team to create study designs tailored to your device.
At what point in my preclinical medical device testing program should we “freeze” the design of our device?
Improvements to the medical device can be performed in early phases of development, but a full program of pre-clinical studies needs to be performed on the final product since it’ll be used in the clinical trials, including the same production, sterilization, and packaging method. Therefore, the design freeze needs to happen very early. If changes are made to the medical device after the initiation of the GLP studies used for regulatory submission, the studies may need to be repeated or a smaller bridge study may need to be performed to show equivalence of the products.