News & Updates

FDA AI-Enabled Device Software Guidance January 2025The Food and Drug Administration (FDA) has released a draft guidance document outlining recommendations for the lifecycle management and marketing submissions of Artificial Intelligence-Enabled Device Software Functions (AI-DSFs). This guidance, aimed at industry stakeholders, emphasizes a comprehensive Total Product Lifecycle (TPLC) approach to ensure the safety, effectiveness, and equity […]

DPDP 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 personal data by both private and government entities in India. The DPDP Act defines personal data as any information that can be used to identify

USFDA 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 its requirements with the widely recognized International Organization for Standardization (ISO) standard. The move aims to establish consistency in regulatory expectations for device manufacturers across