Since 1938, the US Food and Drug Administration (FDA) established regulations for drug manufacturers. Medical gases are considered prescription drugs and are covered by these regulations. The regulations (21 CFR Part 211) have been revised...
Regardless of which industry we work in and whether we are aware of it or not, standards affect all of us, every day of our lives. Some of you may groan at this topic, but...
After a relatively inactive two years where these gases are concerned, the Food and Drug Administration (FDA) is again focusing its attention on medical gas requirements.
Producers and distributors of specialty gases in food and beverages need to know that the new regulations for the Food Safety Modernization Act (21 CFR Part 117) are now officially in effect.
The France-based International Institute of Refrigeration (IIR) Science and Technology council has launched a new Working Group (WG) on ‘whole-body cryotherapy’ (WBC) or ’cryostimulation.’
If you are a large company with more than 500 employees you’re already in the middle of dealing with compliance issues surrounding the provisions of the US government’s Food Safety and Modernization Act (FSMA). As...
Twenty years ago, the vast majority of bulk medical gas systems (BMGS) were installed at large hospitals. It was a simplistic supply chain as these systems received product shipments directly from the air separation unit...
The design of traditional medical facilities is rapidly changing in response to the evolution of medical technology and methods of patient care. An increasing number of facilities are expanding the scope of their research, requiring...
A key vector that helps organizations sustain, grow, and establish themselves as business leaders in their respective fields on the global stage is a strong business management framework, or infrastructure, that can support and sustain continuous...
Bedfont® Scientific Limited, a medical device manufacturer, has passed its latest US Food and Drug Administration (FDA) inspection with flying colours.
