SOPs for Medical Device Startup: 7 Key Medical Device SOPs
Medical device industry is highly regulated. Various documents are required to demonstrate regulatory compliance. Standard operating procedures (SOPs) are one such essential document required for medical device approval and market launch. SOPs outline the framework...
4 Key Steps for Effective Internal Audit of ISO 13485:2016 QMS
QMS helps ensure medical devices being manufactured are consistently meeting strict quality standards, thereby ensuring their safety and efficacy. A robust QMS helps medical device manufacturers reduce errors, minimize risks, and ensure product quality. The ISO...
Effective Risk-Based CAPA in Quality Management System
Corrective Action Preventive Action (CAPA) focuses on eliminating the root cause of non-conformities It is a systematic approach aimed at mitigating the risks of undesirable events and non-conformities. CAPA forms the core of quality management system (QMS) in...