Clean audit results confirm past compliance but say little about future performance. As products, markets, and regulations ...

Quality teams already use general-purpose AI for deviations and submission drafts without validation. Regulators expect ...

Passing inspections no longer signals that a growth-stage biotech can sustain clinical-stage complexity. The gap between ...

Spreadsheets and siloed quality systems conceal five compounding exposures, from single-person knowledge dependencies to ...

PFAS exposure for device manufacturers no longer hinges on a single rule or a single material. FDA has drawn a firmer line around fluoropolymers, yet state reporting requirements, a still-evolving EU ...

Compendial standards rarely change without consequence for testing laboratories, and the recent revision to USP <788>, Particulate Matter in Injections, is no exception. Written by Lori Graybill, ...

For years, manufacturers relied on a table-based approach to determine allowable ethylene oxide residual limits, an approach that didn't adequately account for vulnerable patient populations or device ...

Building certainty under uncertainty is the defining challenge of drug and device development. Whether the work starts with formulation strategy or design reviews, the underlying priorities converge ...

For years, Chile has occupied a strange position in Latin American medtech strategy. It was sophisticated, stable, commercially attractive, and comparatively easy to enter. For many medical device ...

India’s Ministry of Health and Family Welfare published a draft notification in its Official Gazette (G.S.R. 515(E), dated June 23, 2026) ¹ proposing amendments to the Medical Devices Rules, 2017 that ...

FDA has now completed just over 100 inspections under its new Quality Management System Regulation, and the agency has begun sharing preliminary observations from those inspections. Early FDA findings ...