CDRH Report: Quality Management Insights For Medical Device Manufacturers
FDA's Center for Devices and Radiological Health (CDRH) provided a glowing self [...]
8
05, 2017
3
04, 2017
FDA Warning Letters Emphasize Document Control System Compliance
First-quarter 2017 Food and Drug Administration (FDA) warning letters emphasize [...]
14
03, 2017
Cybersecurity Management Expectations Clarified By FDA
The FDA has made it abundantly clear that it expects medical device manufacturer [...]
6
03, 2017
Increased QMS Compliance Inspections For International Life Science Manufacturers
International QMS compliance inspections of pharmaceutical and medical device ma [...]
20
02, 2017
Document Management + CGMP Compliance
Data integrity within your document management process is a critical component o [...]
14
02, 2017
Quality Management Efforts: 2017 CDER Guidance Agenda Impact
Quality management efforts could be impacted by what appears to be an aggressive [...]
30
01, 2017
Risk Management Best Practices for Cybersecurity Compliance
A new FDA guidance concerning risk management helps medical device manufacturers [...]
23
01, 2017
Tougher Quality Management Enforcement By FDA In 2017
Quality management, always an FDA focus during inspections, could become even mo [...]
31
10, 2016
Is Your Change Control Program Ready for FDA 510(k) Scrutiny?
A trio of FDA 510(k) guidances demonstrate how important it is for medical device manufacturers to get a firm grip on document management and change control – especially when working within the Third Party (TP) Review Program or trying to determine if a medical device change warrants a new 510(k). The agency is attempting to make it easier on device makers if they understand how to work within the new system.
