Risk Management
X2 Biosystems is Combating Football Concussions with Data and Devices
Feb 27, 2013
Starting in the 2013 season, the NFL is going to have a new tool in its fight against concussions - a neuro test developed by X2 Biosystems to assist in...
Norgren RM1 Pressure Regulator for Medical Gases
Dec 03, 2012
A company that works in pneumatic motion and fluid control technologies have released a new pressure regulator targeted at medical device manufacturers that...
Medical Device Recalls Hit 2-Year High in Q2 2012
Aug 23, 2012
The number of medical device products affected by recalls hit an eight-quarter high in the second quarter of 2012, exceeding 100 million units for the first...
MD&M East Session to Address Risk Management
Apr 24, 2012
With high-profile failures of products such as metal-on-metal hip implants in the news and consumer advocates clamoring for safer medical devices, risk...
Proactive Postmarket Safety Surveillance in Scrutinized World
Feb 22, 2012
Medical device companies face an expanding set of legal and regulatory requirements to address risks and concerns around product safety. Scrutiny from the...
Medical Device Safety System Design: A Systematic Approach
Jan 24, 2012
As technology advances, medical devices that improve disease diagnosis and the treatment of illness or injury are introduced. Many of these lifesaving medical...
Consumers Union Seeks Stronger Device Law
Dec 19, 2011
The Consumers Union (CU) is getting involved in the debate over the medical device approval process, asking Congress to bolster FDA’s standards for...
Theft of Boston Scientific Devices Likely an Anomaly
May 27, 2011
When one thinks of the things thieves usually steal, medical devices do not usually come to mind. Some no-goodniks were apparently thinking outside of the box...
MD&M East 2011 Preview: Making Devices for the People
May 04, 2011
For all of the aseptic technical details and analytical thinking that goes into developing medical devices, it’s a fundamentally human enterprise. Humans...
Collateral Standards for IEC 60601-1
Apr 27, 2011
Collateral Standards The general requirements of 60601-1 apply to all medical electrical equipment and part 2 standards apply to specific categories of medical...