Media & Press

Medical Product Outsourcing

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The Evolution of Chemical Characterization for Medical Devices

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A look at how chemical characterization practices for medical devices have advanced alongside evolving regulatory expectations.

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BrightTALK

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Medical Device Chemical Toxicological Risk Assessments

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A webcast covering the role of toxicological risk assessment within the medical device chemical characterization process.

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Regulatory Toxicology and Pharmacology · ScienceDirect

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Report on Investigation of ISO 10993-12 Extraction Conditions

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Peer-reviewed research examining extraction conditions under ISO 10993-12 and their effect on chemical characterization outcomes.

ONdrugDelivery

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Extractables/Leachables Testing Considerations for Single-Use Systems

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A closer look at the E&L testing considerations unique to single-use systems in biopharmaceutical manufacturing.

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Lab Manager

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Foresight in Foundation: Strategically Scaling Specialty Labs for Future Success

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Insights on the strategic planning and foundational decisions behind scaling specialty testing laboratories.

RAQA Today · Apple Podcasts

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ASCA, CLAP, Fraudulent Biocompatibility Data, and You

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A conversation on accreditation programs, data integrity concerns, and what they mean for biocompatibility testing today.

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Med-Tech Insights

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Extracting the Truth: The Importance of Complete Chemical Characterisation

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A discussion of why thorough, complete chemical characterization matters for device safety and regulatory submissions.

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Medical Design and Outsourcing

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What Do Big Changes to ISO 10993-18 Mean for Medtech?

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An examination of the significant revisions to ISO 10993-18 and their practical implications for device manufacturers.​

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Pharma Manufacturing

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What USP <665> Means for the Future of Pharmaceutical Manufacturing

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A look at the new USP <665> standard for plastic components and systems, and what it signals for pharma manufacturing going forward.

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