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...
List of Refurbished Medical Equipment for Import: Key Conditions
In this update, we have provided the revised list of refurbished medical equipment for import provided by the Centre. Additionally, we have listed the major conditions for importing refurbished medical equipment into India. Revised list of refurbished medical...
India Rejects IVD Clinical Trial Waiver: Latest IVD Guidelines
In-vitro diagnostic devices (IVDs) are instruments, reagents, or systems used to diagnose a disease or other health conditions. IVD tests are usually performed in test tubes or other similar equipment outside the body. Moreover, the tests can be performed using...