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FDA AI-Enabled Device Software Guidance January 2025The Food and Drug Administration (FDA) has released a draft guidance document outlining recommendations for the lifecycle management and marketing submissions of Artificial Intelligence-Enabled...
Read MoreDPDP Act, 2023 & EU GDPR Comparison The Digital Personal Data Protection Act, 2023 (DPDP Bill) passed on August, 2023 is intended to regulate the collection, processing, and use of...
Read MoreUSFDA Medical Devices QS Regulations harmonization with ISO 13485 standard The US Food and Drug Administration (FDA) has published the long-anticipated final rule on Quality Management System Regulation (QMSR), aligning...
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