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.
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.
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.
Technology and Quality Data: Is Your Organization Keeping Up? Quality data have a direct impact on operational and economic performance in various areas—from research and development (R&D) to manufacturing, to the supply chain.
Removing Silos: The Value of an Integrated Quality and Document Management System (DMS) Integrating your quality management and DMS adds value to each solution, ultimately improving performance, ensuring compliance and visibility, and minimizing risk.
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.
5 Functions that elevate your QMS Many life sciences manufacturers have a growing interest in cloud-based quality management solutions. But the platform on which your QMS runs is as important as the QMS product itself.
