Risk Management Best Practices for Cybersecurity Compliance
A new FDA guidance concerning risk management helps medical device manufacturers [...]
30
01, 2017
23
01, 2017
Tougher Quality Management Enforcement By FDA In 2017
Quality management, always an FDA focus during inspections, could become even mo [...]
16
12, 2016
Risk Management + Adverse Event Reporting: FDA Guidance
Risk management and adverse event reporting protocols for medical device manufac [...]
8
11, 2016
Weak CAPA Programs Hit Globally by FDA Warnings
Life sciences companies around the world better make sure their Corrective and Preventive Action (CAPA) plans are in good shape before an inspector comes calling.
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.
24
10, 2016
What You Need To Know About the FDA’s Mixed Device PMA Approval Report Card
If working with the FDA sometimes feels like reading tea leaves the Quarterly Update on Medical Device Performance Goals gives us more than our usual share of relatively hard data.
14
10, 2016
How Strong is Your QMS Program? New International Meddev Rules Challenge Complacent Organizations
It's time to get your compliance programs in order to meet some looming international regulatory compliance demands, experts including former Food and Drug Administration officials say. Having a firm grip on quality management (QMS) processes - especially document management and change control - will be critical to comply with such a disparate group of regulations working with so many regulatory bodies.
27
09, 2016
Cloud for quality and compliance management: A primer for life sciences companies
Here's what life sciences companies moving their quality and compliance management tools to the cloud can expect.
19
09, 2016
RAPS Preview: FDA CDRH Director Shuren Talks Priorities
FDA CDRH or Center for Devices and Radiological Health Director Jeff Shur [...]
5
11, 2015
FDA Eases Up a Bit on Enforcement Gas Pedal as Warning Letters Decline
Medical device warning letters and domestic inspections continue to show a slow [...]
