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complete procedure to meet

Complete Procedure to Meet the CDSCO License Mandate of Class C & D Non-Notified Medical Devices

Overview of the CDSCO License Mandate The Central Drugs Standard Control Organisation (CDSCO) is the regulatory body that manages medical device registration in India under the Ministry of Health & Family Welfare. The main aim of CDSCO is to ensure that medical devices are...

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The Future of SaMD

Overview  The future of (SaMD) Software as a Medical Device will see breakthroughs in Artificial Intelligence-based diagnostics, personalised treatments, and remote monitoring. Emerging trends emphasise real-time data integration, stronger regulatory measures, and...

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Understanding SaMD

Overview  Software as a Medical Device refers to software applications designed for medical purposes, such as diagnosis, treatment, or monitoring, without being part of a physical device. Software as a Medical Device...

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Quality Management Systems for SaMD Best Practices and Standards OG

Overview  Quality Management Systems for SaMD requires compliance with regulatory standards, implementation of robust quality management systems, and risk management through design controls, testing, and post-market surveillance. It also involves maintaining thorough...

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Clinical Validation of SaMD What You Need to Know OG

Overview  Clinical validation of Software as a Medical Device (SaMD) ensures a software's safety and effectiveness for its intended medical use. It involves rigorous testing and evidence collection to demonstrate that the...

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