Supporting Your Medical Device Development

From proof-of-concept to pivotal efficacy and safety evaluations, Charles River supports developers and manufacturers of medical devices with a broad range of services that include GLP-compliant specialty histology techniques with high-throughput plastic capability and advanced imaging methods. As needed, we customize histology approaches to maximize the yield of information from medical device specimens. We routinely integrate relevant imaging methods (e.g., high-resolution radiography, 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.

Medical Device Pathology Services

  • Protocol preparation and review
  • FDA pre-submission meeting participation
  • Necropsy support
  • Sample preparation
  • Plastic and paraffin embedding
  • Sectioning of hard and softer materials (metals and alloys, ceramics and glasses, polymers, and others)
    • Intact stents, scaffolds
    • Pacemaker leads
    • Heart valves
    • Large metallic and/or hard plastic devices
    • Bone and dental devices
    • Sutures, meshes
    • Biomaterials
    • Ocular devices
  • Histopathology
  • Peer review
  • Morphometric evaluation
  • High-quality gross photodocumentation
  • High-quality microphotographs
    • Imaging techniques
    • Faxitron x-rays
    • Bone densitometry (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)