NERC CIP Violations are a Lesson in Management and Modernization
The recent Notice of Penalty and Enforcement Action of $10M to a Registered Enti [...]
20
02, 2019
7
08, 2018
AssurX Receives HIPAA and HITECH Compliance Type 1 Attestation
Morgan Hill, CA – August 8, 2018 - AssurX,Inc. (AssurX), a leading provider of e [...]
2
08, 2018
NERC to Expand CIP Reliability Standards
The Federal Energy Regulatory Commission (FERC) issued Order No. 848 on July 19, [...]
3
10, 2017
Take Action for ISO 13485:2016 Certification Preparedness
ISO 13485 has undergone its first major overhaul of manufacturing system require [...]
10
04, 2017
China Addresses Life Sciences Regulatory Compliance Concerns
China has often faced criticism for lax regulation of drug and medical device ma [...]
3
04, 2017
FDA Warning Letters Emphasize Document Control System Compliance
First-quarter 2017 Food and Drug Administration (FDA) warning letters emphasize [...]
28
03, 2017
FDA States Clear cGMP Expectations for Combination Products
The Food and Drug Administration (FDA) recently released a final guidance on Cur [...]
14
03, 2017
Cybersecurity Management Expectations Clarified By FDA
The FDA has made it abundantly clear that it expects medical device manufacturer [...]
6
02, 2017
NERC CIP Cybersecurity Risk Management: Being Proactive in 2017
NERC CIP cybersecurity risk management efforts by savvy utility grid operators h [...]
30
01, 2017
Risk Management Best Practices for Cybersecurity Compliance
A new FDA guidance concerning risk management helps medical device manufacturers [...]
