Insights
Clinical Evaluation Requirements for Cardiovascular Medical Devices in India
For cardiovascular medical devices—such as stents, pacemakers, and heart valves—the path to...
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Cybersecurity, AI Algorithms, and CDSCO’s Position on SaMD – What Indian manufacturers must know
Software as a Medical Device (SaMD), especially AI/ML-enabled SaMD, is reshaping diagnosis,...
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CDSCO Non-Predicate Pathway for Cardiovascular Devices: A Regulatory Roadmap for Manufacturers
India’s Growing Cardiovascular Device Market The burden of cardiovascular disease in India...
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Sterilization Validation & GHTF Harmonization for the Indian Market
Sterilization validation is more than a regulatory requirement; it is a vital...
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