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...
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...
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...
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...
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...
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...
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...
Apr 27, 2011
Although the transition period for the third edition of the medical electrical equipment standard (IEC 60601-1:2005) doesn’t end until 2012, there are...
Apr 22, 2011
As the battle rages on in Washington over the nation’s overspending and physicians leave their traditional practices for premium-driven boutique...
Feb 23, 2011
Risk evaluation and mitigation strategy (REMS) is a regulatory technique implemented by FDA to ensure that the benefits of a specific drug outweigh its...