BLOG Post-Market Surveillance: UDI Compliance for Class I Devices Moves Forward with New Deadline The FDA established the UDI system to identify medical devices sold in the United States from manufacturing through patient use, which would ultimately modernize post-market surveillance. Learn more
BLOG Uncovering the Root Cause and Overcoming Challenges Along the Way Root cause analysis (RCA) is the process of drilling down to find the causes of the problem so corrective and preventive action can be taken. Learn more
BLOG Shaping the Future of Quality at the RQA Virtual European QA Congress "Transformation is a dramatic change. It is an alteration. It is not doing the same thing we did thirty years ago but now using a computer." Learn more
BLOG Get Ready: The Latest Version of MIR 7.3 Is Coming The EU manufacturer incident report (MIR) v7.3 is set to be published soon. The European commission has provided... Learn more
BLOG Sparta Experts Present Their Insights on Digital Quality Transformation and Supplier Management On March 30th and 31st, Sparta Systems, A Honeywell company, was a proud platinum sponsor of the 5th... Learn more
BLOG It’s Time to Harmonize: What QMSR Means to Medical Device Organizations "When adapting to the new rule, the best advice I can give is to take it section by section and have buy-in from top management." Learn more
BLOG How Technology Simplifies Supplier Audits The benefits of remote audits include lower costs, no travel restrictions, no logistical constraints, better use of resources and the ability to continuously monitor suppliers. Learn more
BLOG Integration of Quality Management and Manufacturing Automation Systems: The Key to Enabling Quality by Design The benefits of enabling Quality by Design with AI-driven quality operations include connecting AI-enabled quality management and batch automation to provide real-time visibility, using real-time critical process parameter alerts to provide early detection, and more. Learn more
BLOG Overview: Sparta Experts Speak at the RQA International QA Conference Did you miss it? Here are some highlights from Sparta’s expert sessions. Learn more