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...
Starting an IVD Manufacturing Plant in India: Your Quick Guide
In this blog, we have curated a detailed guide for starting an IVD manufacturing plant in India. Additionally, we have discussed the necessary CDSCO license required for setting up an IVD manufacturing facility. What are IVDs? IVDs or in vitro diagnostic devices are...