Medical Device

The medical device industry is highly regulated and requires quality systems to be assessed for products to be manufactured. From stents to regenerative medicines, the medical device manufacturing sector is highly diversified and is known for producing high-quality products using advanced technology.

Through a comprehensive manufacturing support portfolio, Charles River helps medical device companies address high-throughput needs, streamline testing and accelerate in-house investigations. We also have experience guiding clients through the current regulations and providing testing services related to medical devices.

Cytotoxicity Testing

  • MEM Elution Test

Sensitization Testing

  • Guinea Pig Maximization Test

  • Murine Local Lymph Node Assay

  • Closed Patch Test

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Microbiology Support

Multiple options for testing are available to satisfy different global compendial guidelines.

Medical Device Pathology

From proof-of-concept stage to pivotal safety and efficacy evaluations, our pathologists offer the range of services you need.

Industry News

Read a recent American Pharmaceutical Review article entitled "Rapid Quantitative Endotoxin Analysis of Biopharmaceutical Samples Using a Multi-cartridge System."

Musculoskeletal Pathology

Our fully integrated approach to bone pathology assists medical device companies in study design, development strategies, regulatory submissions and project execution.