Clinical Validation of SaMD: Vital for Clinical Relevance
Software as a Medical Device (SaMD) is a software intended to be used for medical purposes without being part of a physical medical device. It can perform functions, such as diagnosing, preventing, monitoring, or treating diseases, by analyzing data and providing...
Quality Management System for SaMD: Focus Areas & Principles
Software as a Medical Device (SaMD) refers to a software that is intended to be used for medical purposes. SaMDs are not part of a physical medical device. The software itself is regulated as a medical device, even though it runs independently on computers,...
8 Key MDSAP CAPA Requirements: Your Comprehensive Guide
MDSAP CAPA requirements are a structured, risk-based framework formulated to identify, investigate, and resolve nonconformities while preventing recurrence. Manufacturers must demonstrate robust root cause analysis, effective corrective measures, proactive preventive...
What is New in GSPR? New Changes & How to Comply with Them
EU MDR General Safety and Performance Requirements (GSPR) have recently been updated. The latest changes in EU MDR GSPR have introduced stricter expectations around cybersecurity, clinical evidence, environmental impact, and AI/ML devices. While core compliance areas,...