preclinical medical device pathology · 2020. 4. 7. · we offer a range of plastic embedding...
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[email protected] • www.criver.com © 2020, Charles River Laboratories International, Inc.
Preclinical Medical Device PathologyCharles River has over 20 years of experience providing high-quality, customized pathology services for implantable medical
device studies. Every medical device study is tailored by experienced professionals and study directors based on the
specific device and study goals, to ensure high-quality pathology data for actionable insights.
Skilled staff at in-life facilities located in the United States and Canada can support all kinds of implantable device studies
from early phase non-GLP, to GLP safety/efficacy assessment. Our dedicated medical device necropsy staff and laboratory
facilities provide specialized techniques such as targeted implant retrieval, non-standard tissue trimming, Faxitron™-guided
tissue trimming, and plastic resin embedding. We offer a range of plastic embedding options for evaluation of undecalcified
bone and/or device-tissue interfaces of large and/or metallic devices that are otherwise unsuitable for paraffin embedding.
Our modern laboratory facilities support the sophisticated multimodal pathology evaluations often required by these
studies. We routinely perform microCT imaging, histomorphometry, and scanning electron microscopy with EDS (elemental
analysis) to complement and enhance interpretation of microscopic data by board-certified veterinary pathologists with
training and experience in medical device pathology.
Charles River’s medical device pathology solutions help clients optimize their development with a tailored, thorough,
comprehensive pathology evaluation for better decision-making and streamlined regulatory review.
Device Pathology Services
• Paraffin histology
• Plastic resin histology
• MicroCT
• Histomorphometry
• Immunohistochemistry
• SEM-EDX
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