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IEC 62304 \u2014 Medical Device Software \u2014 Software Life Cycle Processes. International Electrotechnical Commission (standard \u2014 available for purchase\/download from IEC webstore). IEC product page: https:\/\/www.iec.ch\/standard\/62304"},{"key":"2337_CR6","unstructured":"ISO. ISO 13485: Medical devices \u2014 Quality management systems \u2014 Requirements for regulatory purposes. ISO standard page (available from ISO webstore): https:\/\/www.iso.org\/standard\/59752.html"},{"key":"2337_CR7","unstructured":"FDA. eSTAR: Electronic Submission Template and Resource \u2014 FDA medical device submissions resources page. Available: https:\/\/www.fda.gov\/medical-devices"},{"key":"2337_CR8","unstructured":"IMDRF. Software as a Medical Device (SaMD): Key Definitions (IMDRF\/SaMD WG\/N10FINAL:2013). Available: https:\/\/www.imdrf.org\/sites\/default\/files\/docs\/imdrf\/final\/technical\/imdrf-tech-131209-samd-key-definitions-140901.pdf"},{"key":"2337_CR9","unstructured":"IMDRF. 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Global Model Regulatory Framework for medical devices including IVDs (draft; WHO). 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This manuscript is a Comment\/Editorial and does not report original research involving human participants, interviews, or datasets.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics Approval and Consent to Participate"}},{"value":"Not applicable.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for Publication"}},{"value":"The authors declare no competing interests.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing Interests"}},{"value":"Not applicable.","order":5,"name":"Ethics","group":{"name":"EthicsHeading","label":"Clinical trial number"}},{"value":"Large language model (LLM) tools were used to support language editing and clarity during manuscript revision. All substantive content, interpretations, and conclusions were developed by the authors, who take full responsibility for the final text.","order":6,"name":"Ethics","group":{"name":"EthicsHeading","label":"Use of Artificial Intelligence Tools"}}],"article-number":"7"}}