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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Medical Device Services & Resources

Biocompatibility Testing

Medical Device Safety & Efficacy

Medical Device Pathology

QC Microbial Solutions

Medical Device Resources

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Related Products & Services

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.

How can we support your program?

 

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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White Sprague-Dawley rat.

Characterization of an Acute Rodent Osteomyelitis Infectious Model Using a Tibial Intramedullary Implant Inoculation

Chronic osteomyelitis in presence of orthopedic implants is a condition observed in the field of biomaterials as it impairs early bone-implant contact, fixation and integration. In this study, a surgical intramedullary tibial insertion was performed using a titanium wire previously inoculated with Staphylococcus aureus in order to develop an osteomyelitis model in a clinically relevant long bone and in absence of any prophylactic treatment.

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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.

Download the Datasheet