Improving patient care by ensuring medical devices work well together
FMSA includes enhanced focus on supply chain standards
FDA’s Office of Criminal Investigation steps in
Challenges and advantages for implementation
CDRH inspections account for 10–12 percent of all FDA inspections
Automating data management puts the ‘rapid’ in front of ‘prototyping’
On Feb. 1, 2013, WebTrader inboxes with more than 20 documents will be cleaned. No retrievals.
The FDA wields its FSMA authority against Sunland Inc.
Encouraging collaboration between nations on common regulatory issues
Just paying attention, says FDA; that’s hypervigilence, counters EU
Increasing efficiencies for device review
Is the agency stifling medical innovation?
The industry must plan for proactive quality assurance and supply-chain management
Medical device firms are always one recall away from increased scrutiny
Also, expect more frequent and stricter enforcement
To salt or not to salt? That is the question. Well, one of them.
Results of ASQ Salary Survey
Moving target of enforcement priorities will affect midsize device makers
Importer accountability and third-party certification are new challenges
The FDA will not let you have your cake and eat it, too