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,...
10 Key Benefits of MDSAP: Everything You Need to Know
The Medical Device Single Audit Program (MDSAP) is a global framework that satisfies the regulatory requirements of multiple countries. MDSAP reduces duplication and ensures consistent quality product oversight. It is now recognized by several major regulators...