Is your medical device company ready for the QMSR shift? Engineer Aldo Vidinha explains why "checkbox compliance" is over and how the FDA’s alignment with ISO 13485 redefines quality as a connected, ...

Regulators are modernizing their expectations, and it's become clear that validation can no longer function as a point-in-time event.

Bassem Gayed, PhD, Senior Technical Director of CAR-T Process Engineering, Manufacturing Science & Technology at Bristol Myers Squibb, discusses the connection of process validation and CAR-T ...

The authors summarize the current regulatory expectations regarding the number of PPQ batches required and provide potential approaches that can be used to determine and justify the number of PPQ ...

A moldmaker said recently that it sometimes takes him up to eight months to validate a large, high-cavity medical mold. Maybe this surprises you, but it doesn’t surprise many OEMs in the medical and ...

When developing medical device products and the parts that comprise them, engineers must usually decide what elements of the design are critical to function and, therefore, what dimensions require ...

As technology capabilities and customer requirements have evolved, so have gas turbine testing and validation methods. Mitsubishi Hitachi Power Systems believes the proof of its long-term validation ...