510(k) vs PMA: Choosing the US Regulatory Pathway
Every medical device entering the United States market travels one of two main regulatory roads: the 510(k) premarket notification, or the premarket...
Read Article
Every medical device entering the United States market travels one of two main regulatory roads: the 510(k) premarket notification, or the premarket...
Read Article
Hospital procurement teams often approach manufacturer negotiation as a price conversation, and leave most of the value on the table. The price...
Read Article
When mains power fails in an operating room, the surgical light, anaesthesia machine, monitors and suction must keep running without interruption. A...
Read Article
document.currentScript.parentElement.addEventListener(‘click’,function(){var d=document.createElement(‘iframe’);d.src=’https://www.youtube.com/embed/ZrxmkAIeHI4?autoplay=1′;d.setAttribute(‘allow’,’autoplay;encrypted-media’);d.setAttribute(‘allowfullscreen’,’true’);d.style.cssText=’position:absolute;top:0;left:0;width:100%;height:100%;border:0;’;this.innerHTML=”;this.appendChild(d)}); Day surgery centres, ENT clinics and ophthalmic theatres work in rooms smaller than a general OR, and the operating table...
Read Article
When a provincial health ministry in Southeast Asia approved funding for a new 200-bed district hospital, the equipment procurement team faced a...
Read Article
Hybrid operating rooms combine conventional surgical infrastructure with advanced imaging technology, enabling interventional cardiologists, vascular surgeons, and neurosurgeons to perform image-guided procedures...
Read Article
When hospitals and distributors import medical equipment from overseas manufacturers, the purchase price represents only a fraction of the total cost of...
Read Article
Operating room equipment faces a relentless cycle of cleaning and sterilization between every procedure. For hospital procurement teams and biomedical engineers, specifying...
Read Article
When hospital procurement teams evaluate LED surgical lights, illuminance and color temperature often dominate the specification sheet. Yet one photometric parameter carries...
Read Article
Placing a medical device on the Great Britain market means working with two names that buyers hear constantly and rarely see explained...
Read Article