AssurX Focuses on Medical Device Compliance at RAPS Convergence 2020
AssurX is participating in the first virtual RAPS Convergence Conference currently live through September 16, 2020, in Virtual Booth 610. RAPS Convergence brings together the largest community of regu [...]
The Six C’s of a Modern Complaint Management System 2020
Regulators such as FDA, European Commission (EC), ISO 13485 require a product complaint management system that is effective for resolving product quality issues and improving patient safety. Unfortun [...]
Assurx2020 Further Modernizes Efficiencies In Automating Quality Management
Morgan Hill, CA., January 22, 2020, – AssurX, Inc., a leader in enterprise quality management and regulatory compliance software, announced AssurX2020, an expansion of enhancements in the AssurX Quali [...]
Looking Ahead: 2020 Life Sciences Technology Trends
The Life Sciences industry has always been fast-paced and competitive. Changes are influenced by the regulatory landscape, a need for lifesaving products as well as therapies and scientific advanceme [...]
3Analytics Partners With AssurX to Revolutionize IMDRF Coding Using AI
The IMDRF Coding solution integrates seamlessly into AssurX EQMS, ensuring compliance with EU MDR and FDA guidelines while reducing costs by up to 72%. 3Analytics, the first AI enabled eMDR solution, [...]
AI in Medical Device Manufacturing: How It’s Transforming an Industry
In April 2018, the U.S. Food and Drug Administration (FDA) approved the first AI-powered diagnostic system, a software program used to detect diabetes-related vision loss. Since then, the industry ha [...]
Why NERC CIP Compliance Matters: 10 Key Reasons
According to the International Energy Administration, weekly cyberattacks on global utilities more than doubled from 2020 to 2022. Even though there haven’t yet been any cyberattacks in the U.S. that [...]
NERC CIP-013: Cyber Security – Supply Chain Risk Management for Utilities
Supply chain risk management is of paramount importance to cyber security for utilities. That’s because any supply chain disruption can have severe consequences for these critical infrastructure provi [...]
Top 3 Most Violated NERC CIP Standards
According to the North American Electric Reliability Corporation (NERC), CIP standards represented seven of the top ten most frequently violated serious and moderate risk standards in 2022. The three [...]
Aligning Incident Management with ISO 45001 Requirements
The number of ISO 45001 certificates is growing fast, jumping 54% from 2020 to 2021 according to the ISO Survey. This occupational health and safety standard is especially prevalent in manufacturing, [...]
