5 Key Elements of an Effective CAPA System
An effective corrective and preventive action (CAPA) system is the backbone of a robust quality management system (QMS). It ensures that systemic issues are not only corrected but prevented from recurring. An effective CAPA system improves product quality and customer...
Role of Regulatory Affairs in the Medical Device Industry
The regulatory affairs team creates tailored regulatory strategies to ensure smooth market entry and compliance with international standards. They analyze product classification, applicable regulatory guidelines, and submission requirements. Moreover, they prepare and...
Role of Cleanrooms in Manufacturing Sterile Medical Devices
Cleanrooms have a vital role in maintaining the controlled environments necessary for manufacturing sterile medical devices. They offer a sterile and specialised environment. Medical device manufacturers will have to establish effective clean rooms to maintain a...
How to Import Medical Devices from Japan? Comprehensive Guide
Japan is a top global exporter of medical devices, especially in diagnostic and imaging equipment. Japan has a reputation for manufacturing high-quality and reliable products. India has a growing medical device market and increasing demand for advanced healthcare...