AssurX Blog
Straight talk for regulated industries.
Medical Device Industry Endures Tough 2013; 2014 Prospects Not Much Better
It's March, but you could forgive medical device industry leaders if they're still smarting a bit from a generally tough 2013. Several new studies indicate a low level of mergers and f [...]
The Six C’s of Complaints Management Best Practices for Life Sciences
Jeff Mazik, Vice President, Life Science Solutions, AssurX Companies in the Pharmaceutical, Medical Device, and Biotech industries must meet many regulatory requirements for a number [...]
FERC Order to Impose Stricter Physical Security Standards on Electric Utilities
On March 7th, FERC released a new order (Docket No. RD14-6-000) directing the North American Electric Reliability Corporation (NERC) to develop new reliability standards for the NERC r [...]
CDRH 2014 Strategic Priorities Promise Improved IDE, PMA Regulatory Climate
The Center for Devices and Radiological Health or CDRH will focus on encouraging medical device innovation and speeding clinical trials in the coming years, according to its 2014-2015 [...]
NERC and Industry Move in the Right Direction for Greater Reliability
There is a different feel out there in the NERC world, the Electric Reliability Organization (ERO) and the registered entities are working together more than ever since the mandatory i [...]
Medical Device Makers Urged to Play Nicer by Sharing Data
You shouldn't need Barney the giant purple dinosaur to remind you of the playground mantra "sharing is caring," but maybe the medical device industry needs to do some quick Netflix str [...]
