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FDA Releases Draft Guidance on AI-Enabled Device Software Functions

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FDA AI-Enabled Device Software Guidance January 2025The Food and Drug Administration (FDA) has released a draft guidance document outlining recommendations for the lifecycle management and marketing submissions of Artificial Intelligence-Enabled Device Software Functions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 […]

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The FDA’s Pre-determined Change Control Plan (PCCP) is a useful tool that reduces repeat submissions

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Embarking on the journey to secure US FDA 510(k) clearance for your medical device is a crucial step toward market success. In this comprehensive guide, we’ll demystify the intricate process, providing you with a roadmap to navigate the complexities and ensure a smooth clearance journey.

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DPDP Act, 2023 & EU GDPR Comparison

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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

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USFDA Medical Devices QS Regulations Harmonization

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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

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Precision in Practice: Decoding ISO 13485 for MedTech Excellence

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Diving into the intricacies of quality management in the MedTech domain requires a nuanced understanding of ISO 13485. This guide navigates through the essentials, offering insights into the pivotal role this standard plays in shaping the quality landscape within medical device companies.

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Unraveling India’s MedTech Regulatory Landscape: An In-Depth Exploration

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Embarking on a journey through India’s dynamic MedTech regulatory landscape is pivotal for manufacturers aiming to thrive in this burgeoning market. In this comprehensive guide, we’ll delve into the distinctive facets of medical device regulations in India, unraveling the complexities of securing a device license from the esteemed regulatory body, CDSCO (Central Drugs Standard Control Organization).

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