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EU MDR 2017/745 · REGULATION (EU) 2024/1689 · EN ISO 14971 EU MDR + EU AI Act Documentation Kit The technical documentation, risk management, clinical and post-market files of a medical device, with the EU AI Act built in, plus the AI Act procedures. €999 VAT calculated at checkout Get the kit 36 documents ·…
EN ISO 13485:2016/A11:2021 · EU MDR 2017/745 · REGULATION (EU) 2024/1689 ISO 13485 + EU AI Act Documentation Kit A complete ISO 13485 quality management system with the EU AI Act requirements for AI-enabled medical devices written into its procedures. €499 VAT calculated at checkout Get the kit 95 documents · Word and ExcelInstant download…
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