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 safety and efficacy evaluations. We are able to offer an integrated approach to medical device studies with a commitment to scientific excellence, an appreciation for client-specific issues and an understanding of regulatory considerations.
- Protocol preparation
- Necropsy support
- Sample preparation
- Electron microscopy
- Photographic documentation
- Morphometric evaluation
- Plastic embedding and sectioning of all materials (e.g., intact stents, bone devices)
Types of 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)