Charles River offers an integrated approach to medical device studies with a commitment to scientific excellence, an appreciation of client-specific, and an understanding of regulatory considerations. The medical device industry is highly regulated and requires quality systems to be assessed for products to be manufactured.
- Biocompatibility & Safety Testing
- Rapid Endotoxin Testing
- Medical Device Pathology
- Viral Clearance
- Microbial ID
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 offers a range of safety evaluation and biocompatibility services for medical devices, including studies designed in accordance with ISO 10993 and USP guidelines. With capabilities to test many different types of medical devices across multiple therapeutic areas, we will work with clients to design and deliver the most appropriate program for each product.
Biocompatibility & Safety Testing Products & Services
The Endosafe® cartridge technology is our innovative response to our customers’ need for higher sensitivity, greater specificity, and faster quantitative endotoxin results. Designed to optimize and refine our use of LAL, the cartridge technology eliminates a significant amount of the raw material and accessories required for traditional LAL methods while reducing time-consuming preparation and technician variability. Each of our highly flexible rapid testing platforms meet the needs of a variety of sample throughput and different lab sizes and configurations. All support the same cartridge technology for accurate, convenient, and real-time endotoxin testing, glucan concentration determination, and Gram identification.
Rapid Endotoxin Testing Products & Services
Charles River has a more extensive range of expertise in a Good Laboratory Practice (GLP) environment than any other contract pathology group in the world. We support developers and manufacturers of medical devices from the proof-of-concept stage to pivotal safety and efficacy evaluations, and our medical device pathology services offer the broadest possible range of GLPcompliant, specialty histology techniques, and the highest throughput plastic capability.
Class III medical devices that use material of animal origin (e.g., prosthetic valves) bear the risk of viral contamination, and thus may be subject to viral clearance studies. Frequently, such devices also require clinical trials before obtaining regulatory approval in Europe and the US. Charles River has over 20 years of experience in leading clients through the risk assessment, planning, and execution of viral and TSE clearance studies under ISO 22442-3 or FDA Guidance: Medical Devices Containing Materials Derived from Animal Sources (Draft 2014). To eliminate delays and optimize development, we support clients by preparing study concepts to be presented to regulatory agencies for discussion and ensuring acceptance prior to a study’s execution.
Viral Clearance Products & Services
Monitor your facility and products against bacterial contamination.
Data gathered from a well-designed and executed environmental monitoring (EM) program provide critical information for tracking and trending on a routine basis. Accurate and consistent species-level identifications result in more confidence in the control of your environment.
Microbial Identification Products & Services