Medical Device

From stents to regenerative medicines, the medical device manufacturing sector is highly diversified and is known for producing high-quality products using advanced technology. 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.

Surgeons using medical devices.

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Rapid Endotoxin Testing

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.

Central/QC lab with various rapid endotoxin testing equipment

Viral Clearance

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 2007 and FDA Guidance for Industry: Medical Devices Containing Materials Derived from Animal Sources (March, 2019). 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.

Lab technician observing plaque assay results