PLI Scheme Boosts Medical Device Manufacturing in India
India is witnessing a significant push in medical device manufacturing under the government’s Production Linked Incentive (PLI) scheme. As of March 2025, 21 approved
India is witnessing a significant push in medical device manufacturing under the government’s Production Linked Incentive (PLI) scheme. As of March 2025, 21 approved
What is a CDSCO Loan License? A CDSCO Loan License, as defined under the Drugs and Cosmetics Act, 1940, is a license issued to
21 CFR Part 820 ensures your device’s safety and effectiveness. The goal of regulatory affairs is to guarantee that your organization complies with all
This blog discusses the harmonization of FDA QSR with ISO 13485. Those new to the industry are likely to have a lot of questions,
A Validation Master Plan (VMP) is a top-level strategic document that defines how a medical device manufacturer will validate its equipment, utilities, processes,
When developing a medical device, one of the key regulatory obligations manufacturers must meet is maintaining a Design History File (DHF). While most manufacturers