India is aiming to locally manufacture and assemble medical devices. Various components and parts have to be imported to manufacture life-saving medical devices. However, while importing medical device components and essential parts, medical device manufacturers are...
Medical devices form the backbone of the healthcare sector. The diagnosis and prognosis of a disease or a medical condition depends on the effectiveness of the medical device. Hence, medical device entrepreneurs are constantly trying to tap into the potential of the...
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...
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...
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...