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.

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Biocompatibility Testing

Medical Device Safety & Efficacy

Medical Device Pathology

QC Microbial Solutions

Medical Device Resources

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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.

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Close up view on artificial heart prosthesis

Webinar: Environmental & Sterility Assurance Control for Medical Devices

Learn the importance of maintaining a state of control with sound environmental monitoring programs and microbial contamination control within medical device manufacturing facilities.

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Illustration of the cardiovascular system.

Structural Heart Studies

Charles River is well versed in the preclinical assessment of medical devices that treat or cure structural heart defects. Such devices typically target the anatomical structures such as heart valves or conduits between chambers of the heart.

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Scanning Electron Microscopy

Scanning Electron Microscopy Datasheet

Our scanning electron microscope (SEM) can aid your medical device development and safety assessment. We’re able to run a variety of SEM studies to enhance your research and development program.

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