Too much stick, not enough carrot?
Guidance describes framework and process of voluntary CDRH qualification
IAF announces the largest technical trade agreement ever prepared for the medical device standard
Outlook is cloudy with a chance of inspected meatballs
Compliance doesn’t have to be difficult
FDA increases inspections of compounding pharmacies
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