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

We offer cardiovascular device testing through a comprehensive portfolio of models and services.

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.

Learn more about our cardiovascular medical device models


Orthopedic Models for Medical Devices

Charles River offers medical device testing for orthopedic medical devices.

We offer preclinical medical device testing services for your orthopedic program from the proof-of-concept to safety regulatory testing under GLP.

Learn more about our orthopedic medical device models


Additional Preclinical Medical Device Testing Support Services

  • ENT - sinus implants drug delivery | bioresorbable stent
  • Ocular - enucleation, evisceration | orbital implants
  • Dermatology
    • subcutaneous; dermal filler
    • wound healing; hydrogel and wound dressing
  • CNS - shunts
  • Gastroenterology
    • 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.

Talk with our Team

Frequently Asked Questions (FAQs) about Preclinical Medical Device Testing

  • Why is it important to work with a single preclinical medical device testing CRO who has an established track record with regulatory agencies?

    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.

    A preclinical medical device testing CRO should have thorough surgical and imaging expertise for proper device implantation and is already operating in a robust GLP environment to future-proof your development and streamline your program when ready to transition to GLP studies. You’ll enjoy simplified administrative and scientific operations with better tracking of all testing in your program and a unified study report.

    A CRO should have a strong focus on planning and relationships with the regulatory authorities who will be granting approval of your product. A forward-thinking partner might recommend, for example, a non-GLP pilot study to collect maximum data, thus lowering your risk of later problems during your pivotal GLP study. The right preclinical medical device testing partner can also facilitate a critical pre-submission review of your written protocol with the FDA, ensuring that your program is on track. When changes are required, you’ll want to ensure that your partner has the flexibility to adapt the design and execution of your studies to meet evolving expectations.

    By collaborating with the right CRO, your organization can lower costs, reduce stress, and get your product to market faster.

  • 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” preclinical study plan. Having seen a vast array of medical device types under development, our multidisciplinary team of experts uses their deep understanding of efficacy, safety, and regulatory guidelines to develop an appropriate preclinical medical device testing strategy to suit the needs of your device. Our unique combination of regulatory expertise with devices and comprehensive portfolio of preclinical medical device testing 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 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 and immuno-oncology, endocrinology, neuroscience, ophthalmology conditions, and more, medical devices serve numerous therapeutic areas. As a global CRO with over 2,000 scientists, our field experts partner with our dedicated medical devices safety team to create study designs tailored to your device and in compliance with regulatory guidelines.

  • 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.