AEGIS: An Operational Infrastructure for Post-Market Governance of Adaptive Medical AI Under US and EU Regulations
Machine learning systems deployed in medical devices require governance frameworks that ensure safety while enabling continuous improvement. Regulatory bodies including the FDA and European Union have introduced mechanisms such as the Predetermined Change Control Plan (PCCP) and Post-Market Surveillance (PMS) to manage iterative model updates without repeated submissions. This paper presents AI/ML Evaluation and Governance Infrastructure for Safety (AEGIS), a governance framework applicable to a
Record details
Published: 20 March 2026
Source: arXiv
Category: Research
Topics: Regulation · Privacy · Healthcare
Retrieved: 14 July 2026
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How to cite this record
ethics.ai (20 March 2026), “AEGIS: An Operational Infrastructure for Post-Market Governance of Adaptive Medical AI Under US and EU Regulations,” evidence record 6956, https://ethics.ai/record/6956 (originally published by arXiv).
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