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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Biocompatibility Testing

Preclinical Medical Device Testing

Medical Device Pathology

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Microbial ID & Strain Typing

Monitor your facility and products against bacterial contamination with AccuGENX-ID® and AccuPRO-ID®.

Rapid Endotoxin Testing

Responsible, routine sterility assurance programs and quality control test services must also be practiced in parallel to continuously confirm the quality and safety of each new product.

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.