Part I: Enterprise Quality Management System Selection Best Practices
Editor's Note: In this two-part series, you'll learn common pitfalls to avoid an [...]
31
12, 2016
16
12, 2016
Risk Management + Adverse Event Reporting: FDA Guidance
Risk management and adverse event reporting protocols for medical device manufac [...]
14
12, 2016
Risk Management Programs: What The Latest Wave of HIPAA Fines Mean
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.
30
11, 2016
Utility NERC Compliance Programs Challenged by NERC’s New Risk-Based Approach
If compliance with the North American Reliability Corporation (NERC) Reliability [...]
24
10, 2016
Ukraine Cyberattack Represents Wake-up Call for America’s Utility Grid
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."
29
10, 2015
FDA Guidance Answers (Some) Medical Device Cybersecurity Concerns
A new FDA guidance calls on the medical device community to be more proactive wh [...]
14
10, 2015
FDA Inspectors Leave Calling Cards For Medical Device Manufacturers Nationwide
Our latest round of warning letters emphasize the importance for medical device [...]
19
08, 2015
FDA Takes GUDID Offline: Security breach? Or Proactive Measures?
FDA detected a "security vulnerability" earlier this month that spooked it enoug [...]
11
08, 2015
Cybersecurity – A Real Threat to Medical Devices
The FDA just issued a Safety Communication on cybersecurity vulnerabilities of t [...]
4
06, 2015
Large Utilities Power Up with AssurX Enterprise GRC Solution
Increasingly complicated, and disparate, regulatory requirements and a demand fo [...]
