Navigating the Green vs. Clean Dilemma in Medical Device Manufacturing
How med-tech manufacturers are leveraging smarter material engineering and laboratory validation to hit sustainability targets without failing the FDA audit
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Biotechnology & Life Science Products Articles
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Rising Expectations in Clinical and Life Sciences Testing
Stay ahead with data-intensive, digitally connected, and regulation-driven clinical testing lab operations
FDA Premarket Approval (PMA) Testing: Requirements, Standards, and Labortory Support
Connecting with accredited labs worldwide ensures your device moves smoothly through the FDA PMA review process
Testing and Analysis for Filters and Medical Textiles
Ensure the integrity of barrier products. This guide details essential lab protocols for filter media and textiles, from viral filtration efficiency (VFE) to sterilization methods
Evolving Demands in Pharmaceutical & Biopharmaceutical Testing
Investing in early phase potency assays and RMMs and aligning with GMP modernization can future-proof pharma testing labs
Emerging Trends Shaping Modern Laboratory Testing Across Industries
Is your lab prepared for the next wave of regulatory, technological, and client-driven changes?
Compounding Pharmacies and USP <797> Compliance
How contract labs support compounding pharmacies with sterility, potency, and compliance testing under USP <797>
Biopharmaceutical Potency Testing: How Contract Labs Ensure Efficacy and Quality
Potency testing ensures biopharmaceuticals are safe and effective. Find out how contract labs deliver validated assays and global compliance
What is Bioburden Testing?
Understanding the Importance of Ensuring Product Safety and Compliance
Microbiology Challenge Testing: Ensuring Product Safety and Efficacy
By simulating real-world conditions and evaluating a product's ability to resist microbial contamination, challenge testing helps ensure that products are safe, effective, and compliant with regulatory standards.
The Critical Role of Reprocessing Medical Devices in Healthcare Safety
An in-depth analysis of the FDA's 2015 guidance for reprocessing reusable medical devices, driven by patient safety concerns in health care
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