Overview

The rise in use of medical devices as an interventional therapy or delivery tool is changing the preclinical development process. As with other forms of therapy, these devices are subject to an assessment of their safety in order to meet regulatory requirements.

Charles River supports developers and manufacturers of medical devices from the proof-of-concept stage to pivotal efficacy and safety evaluations with a broad range of services include GLP-compliant specialty histology techniques with high throughput plastic capability and advanced imaging methods. As needed, we customize histology approaches on an individual basis to maximize the yield of information from medical device specimens. We routinely integrate relevant imaging methods (e.g., micro-CT, SEM, and others) with pathology data to provide multifaceted safety assessment. Comprehensive pathology reports are prepared with consideration to providing actionable data for relevant phases of device development from preliminary development to efficient regulatory review.

Services

  • Protocol preparation and review
  • FDA pre-submission meeting participation
  • Necropsy support
  • Sample preparation
  • Plastic embedding
  • Sectioning of hard materials
    • Intact stents
    • Pacemaker leads
    • Large metallic and/or hard plastic devices
    • Bone devices
    • Biomaterials
    • Ocular devices
  • Histopathology
  • Peer review
  • Morphometric evaluation
  • High-quality gross photodocumentation
  • Imaging techniques
    • Faxitron x-rays
    • Bone densiometry (DXA, pQCT)
    • Micro x-ray and microCT
  • Comprehensive GLP-compliant reports

Types of Medical Devices

Our technicians and pathologists are experts in anatomical and clinical pathology and can prepare and evaluate all categories of devices:

  • External devices (intact as well as breached or compromised surfaces)
  • External communicating devices (intact natural channels, plus indirect and direct blood paths)
  • Internal devices (bone, tissue and fluid, and blood)