For complex medical device systems, teams must define what must happen across subsystem boundaries, assign responsibility for ...

Tissue-derived materials, hydrogels, absorbables, silicones, and drug-containing components can behave unpredictably under ...

On Sept. 16, 2026, the International Organization for Standardization (ISO) published the sixth edition of ISO 9001. Most medical device professionals shrugged. We live in ISO 13485. We answer to the ...

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 ...

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 ...

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, ...

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 ...

The intersection of healthcare and software engineering has fundamentally transformed the life sciences industry. Software is no longer merely a supportive tool; it is increasingly the primary ...

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 ...

In 2023, the FDA made the electronic Submission Template And Resource (eSTAR) mandatory for most 510(k) submissions. Although eSTAR is not an AI tool, the move was the first definitive leap toward the ...

Auto-injectors are devices designed to simplify the process of administering injectable pharmaceuticals at home. They are particularly useful for individuals who need to self-administer medication on ...

Mesa PCDs (Process Challenge Devices) are innovative, patented tools specifically engineered to support the rigorous demands of ethylene oxide (EO) sterilization processes. These devices incorporate ...