4 Key Components of Effective ISO 13485 Resource Management
ISO 13485 resource management is a critical part of the Quality Management System (QMS) under ISO 13485:2016. ISO 13485 resource management ensures organizations maintain competent personnel, reliable infrastructure, controlled environments, and calibrated monitoring...
Quality Management System: 10 Benefits of an Effective QMS
A quality management system (QMS) is a structured framework designed to ensure consistent delivery of products and services that meet customer and regulatory requirements. It integrates elements, such as document control, training, audits, risk management, and...
MDSAP Remote and Hybrid Pilot Program: Key Insights
MDSAP remote and hybrid pilot program was launched to modernize medical device audits by introducing digital flexibility while preserving regulatory rigor. It emerged as a response to global challenges while ensuring manufacturers remain compliant across multiple...
Benefit-Risk Analysis for 510 (k) Clearance: 4 Key Elements
US FDA 510(k) clearance is a premarket notification pathway for medical devices intended for U.S. market entry. This pathway is essential for devices that are not exempt from FDA 510(K) and is not already legally marketed. Additionally, it is required for devices that...