AssurX Blog
Straight talk for regulated industries.
Audit Management: the Perennial EQMS Straggler
AssurX has been in the business of configuring and implementing Enterprise Quality Management Solutions for two decades. Over that time, it has been a consistent finding that audit ma [...]
Obama Veto Threat Looms Over Medical Device Tax Battle
Michael Causey, Editor-in-Chief,Association of Clinical Research Professionals With medical industry trade groups and many House and Senate members lined up on one side determined to [...]
FDA’s UDI Initiative Continues to Roll Forward
Jeff Mazik, Vice President, Life Science Solutions, AssurX With the close of the 7th Annual UDI Conference in Baltimore late last month. The FDA took another big step forward in prov [...]
Will New User Fees Fuel More FDA Inspections?
For FY 2016, FDA is requesting $4.9 billion to support our essential functions and priority needs, which is $425 million above the FY 2015 enacted level. Of the total funding, $2.7 bi [...]
FDA Warning Letters Hit Device Makers Over CAPA, MDR Failures
It’s been a little while since we checked the FDA’s outgoing mail tray to find out what inspectors are looking for – and often finding. During their visits in the first half of 2015 W [...]
Medical Device Makers Express Optimism About Future – But QA Worries About US Regulatory Burden
Crystal may be clear, but crystal balls, at least metaphorically, are certainly not. The late, great political columnist David Broder with The Washington Post used to run a column at t [...]
