ISO 14971: A Clear Guide to Risk Management Systems
Creating a medical device is about more than just innovation; it is about improving lives safely. For new engineers or business leaders transitioning into the medical...
Is Your AI-Generated Document Compliant? A QC Checklist
Artificial Intelligence (AI) is quickly becoming a valuable tool for medical device developers, capable of drafting everything from technical files to marketing materials in record time....
Understanding IEC 42005
The rise of Artificial Intelligence (AI) and Machine Learning (ML) is rapidly changing the medical device landscape. These powerful technologies offer incredible potential, but they also...
Clinical Decision Support Software: Key Regulatory Insights
Clinical Decision Support (CDS) software is transforming healthcare, offering providers powerful tools to enhance patient care and improve outcomes. As these technologies become more integrated into...
A Practical Guide to Implementing QMSR for QSR and ISO 13468 compliant systems
The FDA's transition from the Quality System Regulation (QSR) to the new Quality Management System Regulation (QMSR) marks a significant shift for the medical device industry....