What question did this study set out to answer?

The review aims to analyze the regulatory and design challenges associated with AI in medical devices.

March 22, 2026Recent Advances in Computer Science and Communications

Artificial Intelligence in Medical Devices: A Holistic Appraisal of Regulatory Paradigms, Design Heuristics and Global Compliance Trajectories

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Authors

CJChirag JainAmity University SCShikha Baghel ChauhanAmity University ISIndu SinghAmity University

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Implication

This review examines regulatory frameworks and design principles of AI in medical devices, suggesting necessary adjustments for safety and compliance.

Key Points

The review aims to analyze the regulatory and design challenges associated with AI in medical devices.
Examined global regulatory frameworks like FDA, EMA, and CDSCO.
Conducted comparative analysis of approval procedures and compliance guidelines.
Critically assessed design principles, emphasizing cybersecurity and interoperability.
Reviewed case studies highlighting advancements and challenges in AI deployment.
Identified discrepancies in technical compliance and the need for explainability in AI.
Highlighted procedural variations across various regulatory bodies.
Emphasized the need for unified regulatory approaches to balance innovation and safety.
Outlined future possibilities like explainable AI frameworks and adaptive regulatory models.

Cite This Study

Jain et al. (2026) studied this question.

synapsesocial.com/papers/69bf898bf665edcd009e93fd https://doi.org/10.2174/0126662558434829251210072150

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Implication

This review examines regulatory frameworks and design principles of AI in medical devices, suggesting necessary adjustments for safety and compliance.

Artificial Intelligence in Medical Devices: A Holistic Appraisal of Regulatory Paradigms, Design Heuristics and Global Compliance Trajectories

Discussion

Member takes

Implication

Key Points

Cite This Study

Artificial Intelligence in Medical Devices: A Holistic Appraisal of Regulatory Paradigms, Design Heuristics and Global Compliance Trajectories

Discussion

Member takes

Implication

Key Points

Cite This Study

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