Developing a New Assistive Technology: Parameters, Standards and Compliance Frameworks
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Abstract
Background: Assistive Technology (AT) development in India lacks a unified compliance and regulatory framework.
Objective: To provide a framework that guides innovators in developing ATs aligned with regulatory, ethical, and quality standards.
Methods: A comprehensive synthesis of national (ICMR, CDSCO, BIS, MoHFW, MeitY, MoSJE) and international (ISO, IEC, FDA, WHO, CE) standards was undertaken to frame a multi-tier compliance pathway.
Results: A structured compliance process integrating user-centric design, safety testing, ethical, clinical validation, and digital interoperability was developed.
Conclusion: The proposed framework enables developers to design, test, and commercialize ATs safely, ensuring compliance, accessibility, and sustainability across India’s regulatory ecosystem.
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References
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