The Department of Health and Human Services (HHS) hit hospitals and other healthcare delivery networks hard in the pocketbook with a wave of big fines zeroing in on security risk management issues between July and October. Is this the end of the fine tsunami? Don't bet on it.
If compliance with the North American Reliability Corporation (NERC) Reliability [...]
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.
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.
Still think all of those concerns about cybersecurity protections on the electric grid are overblown? Try asking the 225,000 people in the Ukraine whose power was cut last December by a Russian hacking group that calls itself "Sandworm."
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.
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.
Here's what life sciences companies moving their quality and compliance management tools to the cloud can expect.
FDA CDRH or Center for Devices and Radiological Health Director Jeff Shur [...]
Medical device warning letters and domestic inspections continue to show a slow [...]
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