Understanding the FDA’s thinking and working with the agency is the best way to accelerate compliance. Two important areas in which FDA commonly finds noncompliance issues are in design control and ...

Remaining competitive in the medical device market requires the ability to improve quality while reducing costs. Sartorius offers various solutions to improve productivity and meet rigorous compliance ...

The medical device industry stands at the convergence of innovative design and stringent regulatory requirements, where design quality engineering serves as the critical bridge between conceptual ...

WEST CHESTER, Pa.--(BUSINESS WIRE)--Archimedic, a medical device development firm that provides Design, Regulatory, and Go-to-Market services to its clients, has launched OpenQMS, an open-access, ...