The wheels of medical device regulation turn slowly at times. But just like The Little Engine That Could, it usually reaches its destination eventually. One of the slowest moving regulations was FDA's ...

Process validation is crucial for ensuring the quality of final products and the safety of these processes for manufacturing personnel and consumers in the pharmaceutical, medical device, and ...

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

In biopharmaceutical manufacturing, consistency is vital but hard to achieve. Turning raw materials into safe, high-quality medicines requires stable processes. However, the living cellular expression ...

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, ...

MAPLE GROVE, Minn., June 22, 2023 /PRNewswire/ -- ZEISS is now offering customers validation solutions for their ZEISS Coordinate Measuring Machines (CMMs). The validation of quality assurance systems ...

Developing a medical device is a lengthy process. Prior to commercial distribution, FDA requires that the manufacturing process for the product be validated. Process validation is defined as the ...

The Digital Medicine Society (DiMe), through its Digital Health Measurement Collaborative Community (DATAcc), has launched a new educational resource designed to help sponsors and technology ...