June, 2013
- By: By Charles Sidebottom, By Charles Sidebottom
13 May 2013 For more than 35 years, IEC 60601-1 has been one of the most widely recognized standards for demonstrating the safety of medical electrical equipment. The IEC 60601 family of standards has long been recognized by regulatory agencies in Europe, North and South America, and Asia as establishing conformance with their regulatory requirements....
June, 2013
- By: By Florian Herrmann and Karsten Aalders, Stollmann, By Florian Herrmann and Karsten Aalders, Stollmann
Part 1 The Health Device Profile along with the IEEE 11073 protocol is enabling a number of specific medical devices to communicate data via multiple logical channels carried by a single master radio channel for compatible device communication. Profiles play a central role in the Bluetooth Specification. They define the entire protocol stack, usually including...
Available Live 3D TEE and new breakthrough ICE catheter to reduce need for two separate cardiac ultrasound systems Andover, Mass., U.S.A. – Royal Philips Electronics (NYSE: PHG, AEX: PHIA) today announced that CX50 xMATRIX, the world’s first portable ultrasound with Philips’ industry leading Live 3D TEE, now offers 2-D Intracardiac Echo (ICE)...
May, 2013
- By: John Koon, Publisher, MEDS Magazine
The medical technology ecosystem is an ever expanding and complex food chain. Most noticeable are the manufacturers building medical devices of FDA class I, II and III such as EKG machines, blood pressure monitors, blood glucose monitors, insulin pumps, ultrasound systems, implantable defibrillators, wearable devices and all sorts of wireless monitors. The list goes on...
May, 2013
- By: by David Hirning MS and Virginia A Lang, PhD, HirnLan, Inc.
Get ahead of stringent design cycles by evaluating the human factors and usability of a device early in the process. When the demands for meeting these requirements come from the FDA, as they almost certainly will, your product and your team will be ready. by David Hirning MS and Virginia A Lang, PhD, HirnLan, Inc....
