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What FDA QSR and ISO 13485 Harmonization Means for Medical Device Companies
The new QMSR explained
A Very Round Object Helps Build a Better Mass Measurement
Being off by a single grain of salt just won’t do
Data Management and Reporting in FDA-Regulated Clinical Trials
Walking you through the guidance and regulations
Fundamentals of Telemedicine Equipment
Now is the time to get started as a remote healthcare professional
Are EVs Losing on Authenticity?
Or are consumers the problem?
The Invaluable Role of Traceable Data in Aircraft
How airlines use nondestructive testing software to document dents
Why Audits Are the Backbone of Manufacturing Quality Excellence
Leveraging internal audits to address issues before they become noncompliance findings
Examples of Preventive Maintenance
A positive counterpoint to reactive and corrective maintenance strategies
Quality Digest Talks Quality With QIMA
Combining expertise with digital solutions to bring accuracy and visibility for quality, safety, and compliance data
The Power of Quality Management Software
A useful tool to manage quality operations and build an effective, safe, and ethical supply chain
NIST Explores AI-Enhanced Monitoring in Manufacturing Processes
Building the Collaborative Robotic Operations Workcell

Shifting to Environmentally Friendly Cleaning Fluids
Manufacturers are pursuing alternatives to cleaning fluids containing PFAS
One Technique, Many Uses
The versatility of Shewhart’s charts
What Is a Class III Medical Device in the US?
They are the only class subject to the premarket approval process
Guide to Choosing the Right Training Management Software
Look for a system that supports compliance with regulatory and standard requirements
Load Cell Reliability and Force Measurement in Healthcare
Essential for ensuring accuracy and safety of procedures and devices
A Baldrige Award-Winning Nonprofit Highlights Organizational Resilience
CORE’s mission is to save and heal lives through donation
Quality Assurance: A Critical Ingredient for Organizational Success
Companies that make wise investments in QA reap the benefits
Is Statistical Process Control Still Relevant?
Part 8: A summary of our series
ISO 9001 Is Being Revised
To retain relevance, ISO 9001 must continue to accommodate evolving realities

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