Artificial intelligence enabled medical devices - Data management
Artificial intelligence enabled medical devices - Data management
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What is PD IEC PAS 63621 - Artificial intelligence enabled medical devices - Data management about? PD IEC PAS 63621 (Edition 1) provides a comprehensive, high‑level framework for managing data used to train, test, or validate artificial intelligence (AI) models within medical devices. It sets out structured requirements covering the entire data lifecycle, from planning and acquisition through to use, monitoring, storage and eventual decommissioning. The standard addresses essential considerations such as data quality, suitability, integrity, privacy, security, bias mitigation, traceability, version control, documentation and governance. It also integrates AI‑specific data processes into a medical‑device‑grade quality management system (QMS), ensuring data handling supports the safe, reliable and effective performance of AI‑enabled medical technologies.
Who PD IEC PAS 63621 - Artificial intelligence enabled medical devices - Data management for?
This PAS is intended for all organizations involved in the development, deployment, or support of AI enabled medical devices, including:
Medical device manufacturers working under BS EN ISO 13485 who need full lifecycle data management.
Data scientists, machine learning engineers and technical teams responsible for dataset creation, annotation, quality assurance and verification. Quality and regulatory affairs professionals who manage documentation, conformity evidence and risk management. Clinical data providers and external data suppliers, such as hospitals, research institutions and third party data platforms. Auditors, assessors and regulatory bodies evaluating the robustness and safety of AI related data practices.
What does PD IEC PAS 63621 - Artificial intelligence enabled medical devices - Data management cover? ...
Упомянутые в описании и другие стандарты PD