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 ...

Many drug–device combination products can be developed to achieve the therapeutic goal and still face significant challenges in the manufacturing phase. Laboratory performance might be different from ...

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 ...

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 ...

A structural engineer who has spent years studying how bridges fail is not the same as one who has only studied how they're built; both can read a blueprint, but one of them reads it differently. The ...

Medical device manufacturers with regulatory plans in Latin America often treat translation as a procurement task. Send the instructions for use (IFU), labeling, protocol, investigator brochure, or ...