What FDA QSR and ISO 13485 Harmonization Means
On Feb. 23, 2022, the U.S. Food and Drug Administration (FDA) released its proposed rule for the new Quality Management System Regulation (QMSR).
On Feb. 23, 2022, the U.S. Food and Drug Administration (FDA) released its proposed rule for the new Quality Management System Regulation (QMSR).
Creating a well-run facility isn’t as simple as it appears. It requires meticulous planning, dedicated resources, and a keen eye for detail to ensure that all elements, from the largest machines to the smallest fixtures, function as intended.
While recent economic reports on inflation have signaled positive signs for the future, frontline industry turnover rates remain high.
It’s been a long and arduous road, but you’re almost ready for that first production run.
Along the coasts and in many countries, seawater is widely used for cooling systems at power plants, as well as for some mining and industrial processes.
Mistakes around standard operating procedure (SOP) management are widespread and costly, especially given the pace of change in manufacturing today.
Your company probably has an internal process for a large purchase like an eQMS. In midsize-to-large medtech companies, you’ll likely find this process in the finance department, or perhaps in a dedicated purchasing department operating under finance’s umbrella.
Sometimes you fire someone who doesn’t deserve it. Your job as a leader is to admit the mistake and do your best to rectify it properly as soon as possible.
Additive manufacturing (AM) and AI are two of the most exciting fields in technology today. 3D printing has revolutionized manufacturing and design, allowing for the creation of complex objects with ease.
As industries around the world work to make their process and products not only automated but also autonomous, there has been an explosion in the use of detection and ranging systems during the last 20 years.