{"product_id":"iso-13485-medical-device-file-labelling-kit","title":"ISO 13485 Medical Device File \u0026 Labelling Kit","description":"\u003cp\u003eBuild the medical device file clause 4.2.3 requires for each device type or family, in the format your market expects: ISO 13485, US FDA or EU MDR technical documentation, with IFU templates and a submission cross-reference.\u003c\/p\u003e\u003ch2\u003eWhat's inside (11 files)\u003c\/h2\u003e\u003cul\u003e\n\u003cli\u003e\n\u003cstrong\u003eISO 13485:\u003c\/strong\u003e Instructions for Use Template; Medical Device File Index; Medical Device File Template.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eUS FDA:\u003c\/strong\u003e Device Master Record Register - US FDA; Labeling and IFU Template - US FDA; Medical Device File Template - US FDA.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eEU MDR:\u003c\/strong\u003e IFU Template - EU MDR; Technical Documentation Index - EU MDR; Technical Documentation Template - EU MDR.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eRegulatory Cross-Reference:\u003c\/strong\u003e Regulatory Submission Cross-Reference.\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch2\u003eHow to use it\u003c\/h2\u003e\u003col\u003e\n\u003cli\u003eChoose the template set for your market (ISO 13485 only, US FDA or EU MDR).\u003c\/li\u003e\n\u003cli\u003eCreate one medical device file per device type or family and complete the index.\u003c\/li\u003e\n\u003cli\u003eLink labelling and IFU versions to the file.\u003c\/li\u003e\n\u003cli\u003eUse the cross-reference sheet to map the file to your submissions.\u003c\/li\u003e\n\u003cli\u003eKeep the file current through design and process changes.\u003c\/li\u003e\n\u003c\/ol\u003e\u003ch2\u003eWho it's for\u003c\/h2\u003e\u003cp\u003eManufacturers preparing a medical device file or technical documentation for ISO 13485, FDA or EU MDR.\u003c\/p\u003e\u003ch2\u003eGood to know\u003c\/h2\u003e\u003cul\u003e\n\u003cli\u003eInstant download. Editable Microsoft Office files, no macros.\u003c\/li\u003e\n\u003cli\u003eIncludes a Start Here guide with the contents and how to use them.\u003c\/li\u003e\n\u003cli\u003eLicensed for one organization, including its sites.\u003c\/li\u003e\n\u003cli\u003eTemplates don't reproduce ISO standards. You need your own licensed copies.\u003c\/li\u003e\n\u003cli\u003eAdvisory notice and field action templates are in the \u003ca href=\"\/products\/iso-13485-complaint-handling-pms-vigilance-kit\"\u003eComplaint Handling, PMS \u0026amp; Vigilance Kit\u003c\/a\u003e.\u003c\/li\u003e\n\u003cli\u003eAlso in the \u003ca href=\"\/products\/iso-13485-complete-qms-kit\"\u003eISO 13485 Complete QMS Kit\u003c\/a\u003e, which costs less than buying kits separately.\u003c\/li\u003e\n\u003c\/ul\u003e","brand":"ISO Cloud Consulting","offers":[{"title":"Default Title","offer_id":50498932310210,"sku":"ICC-13485-MDF","price":79.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0709\/8361\/4658\/files\/iso-13485-medical-device-file-labelling-kit.png?v=1790151005","url":"https:\/\/isocloudconsulting.com\/products\/iso-13485-medical-device-file-labelling-kit","provider":"ISO Cloud Consulting","version":"1.0","type":"link"}