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.
Sparta Connection 2022 Recap: Reunited and Reconnected Last month, Sparta Systems reunited in person for the highly anticipated return of Sparta Connection. Attendees gathered at...
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.
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."
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...
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...
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."
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.
How Pharmaceutical Quality Drives Performance While many pharmaceutical and biotech companies have begun investing in their quality systems, it’s not uncommon to still...
