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,...
10 Best Practices for Internal Auditing of ISO 13485:2016 QMS
Internal auditing of ISO 13485:2016 QMS aims to verify compliance, identify nonconformities, and strengthen the medical device quality system. This structured process ensures audit readiness, regulatory alignment, and continuous improvement. Internal auditing of QMS...
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...