Developing a New Assistive Technology: Parameters, Standards and Compliance Frameworks
DOI:
https://doi.org/10.56450//JEFI.2025.v3i1Suppl.009Keywords:
Assistive Technology, Compliance Framework, Standards, AccessibilityAbstract
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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Copyright (c) 2025 Hitesh K Sharma, Ashoo Grover, Ravinder Singh (Author)
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