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.
Quality Challenges Facing the Medical Device Industry Medical device companies need a solution that mitigates quality challenges with supply chain quality management, complaint handling and reporting processes.
A Journey Beyond Proactive Quality: What We Learned at Sparta’s Virtual Series On June 8th, Sparta kicked off its two-day Digital Transformation in Quality virtual series with a welcome keynote...
Paving the Way to Proactive Quality: Tips for a Successful Journey Are you simply reacting to quality events or are you preventing them from occurring in the first place?
Simplify and Standardize: The Power of Quality Process Accelerators A good quality management solution is intuitive, simple to use and encourages user adoption. This is the basis of Sparta’s Quality Process Accelerators (QPA).
Being Bimodal Regardless of industry or company size, all Quality leaders share these five key imperatives.
Get ready for the new European Medical Device Regulation UPDATE: It is confirmed that, due to the Covid-19 pandemic, the MDR is delayed. Please read Sparta’s update about...
What the EU MDR delay due to the Coronavirus pandemic means for you The new EU Medical Device Regulation was pushed back a year. What do you do? We interviewed Sparta...
Quality vs. Compliance: What is the difference and what are the common pitfalls? As a life sciences manufacturer, compliance with industry regulations is a top priority for your quality management team....
