In the medical device world, laser welding encompasses a wide range of applications and part sizes. However, when laser-welding process cannot be fully verified, FDA requires that manufacturers ...

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, ...

In the rapidly evolving healthcare landscape, medical devices play a pivotal role in enhancing patient care and improving health outcomes. The road to getting these devices from concept to patient use ...

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 ...

In the lab, innovation drives the development of new technology to expand research and overcome technical challenges in healthcare, pharmaceuticals and beyond. Automation is revolutionizing ...

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 ...

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