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 ...

Learn more about Quality by Design principles and how they can be applied in drug product development to bring better biologics to patients faster. Quality by Design (QbD) has transformed the approach ...

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 ...

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 ...