Medical Device
October 25, 2023
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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November 4, 2024
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...
Blog
November 4, 2024
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...
Blog
October 22, 2024
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...
Blog
October 22, 2024
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...
Regulatory Update
October 16, 2024
Regulatory Update
September 11, 2024
Regulatory Update
September 4, 2024
Regulatory Update
September 4, 2024
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