# Regulatory Challenges in AI/ML-Enabled Medical Devices: A Scoping Review and Conceptual Framework

**Type:** Papers  
**Canonical URL:** https://scholariq.org/papers/regulatory-challenges-in-ai-ml-enabled-medical-devices-a-scoping-review-and/

## Facts

| Field | Value |
| --- | --- |
| Author Names | Sanju Kaladharan,Dhanya Manayath,Rejikumar Gopalakrishnan |
| Citations | 11 |
| DOI | 10.1115/1.4066280 |
| Fields | Economics, Econometrics and Finance,Medicine,Social Sciences |
| Open Access | false |
| OA Status | closed |
| OpenAlex ID | https://openalex.org/W4401981503 |
| Type | article |
| Year | 2024 |

## Paper authors

- [Sanju Kaladharan](https://scholariq.org/researchers/sanju-kaladharan/)
- [Dhanya Manayath](https://scholariq.org/researchers/dhanya-manayath/)

## Paper journal

- [Journal of Medical Devices](https://scholariq.org/journals/journal-of-medical-devices/)

## Paper primary topic

- [Artificial Intelligence in Healthcare and Education](https://scholariq.org/topics/artificial-intelligence-in-healthcare-and-education/)

## Paper topics

- [Artificial Intelligence in Healthcare and Education](https://scholariq.org/topics/artificial-intelligence-in-healthcare-and-education/)
- [Ethics and Social Impacts of AI](https://scholariq.org/topics/ethics-and-social-impacts-of-ai/)
- [Health Systems, Economic Evaluations, Quality of Life](https://scholariq.org/topics/health-systems-economic-evaluations-quality-of-life/)

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Source: ScholarIQ — public research metadata, principally OpenAlex. See https://scholariq.org/sources/ for provenance and https://scholariq.org/methodology/ for what these figures mean.