{"product_id":"full-technical-documentation","title":"Full Technical Documentation","description":"\u003cdiv data-live-text-setting=\"section.template--15232249266234__multirow_KiEyWj.block.row_hCnPhV.text\" class=\"image-with-text__text rte body\"\u003e\n\u003cp\u003eFull package of Technical Documentation is included all templates that required for Compliance with EU MDR 2017\/745. Each template is included required sections, requirements, information of how to complete the template as per requirements and 1 example for better understanding the requirements and filling up the template. This package is included:\u003c\/p\u003e\n\u003cp\u003e- Product Description and technical documentation content\u003c\/p\u003e\n\u003cp\u003e- GSPR Checklist (as per Annex I MDR)\u003c\/p\u003e\n\u003cp\u003e- Usability Engineering (as per \u003cspan\u003eIEC 62366-1 \/ EN 62366-1)\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e- Risk Management (Plan \u0026amp; Report) as per ISO 14971\u003c\/p\u003e\n\u003cp\u003e- Clinical Evaluation (Plan \u0026amp; Report)\u003c\/p\u003e\n\u003cp\u003e- Software Validation (Plan \u0026amp; Report) as per IEC 62304\u003c\/p\u003e\n\u003cp\u003e- Sterilization validation (Plan \u0026amp; Report)\u003c\/p\u003e\n\u003cp\u003e- Design and manufacturing of product\u003c\/p\u003e\n\u003cp\u003e- Label and IFU\u003c\/p\u003e\n\u003cp\u003e- EU Declaration of Conformity\u003c\/p\u003e\n\u003cp\u003e- Biological Evaluation (Biocompatibility) as per ISO 10993 series\u003c\/p\u003e\n\u003cp\u003e- Pre-clinical study report\u003c\/p\u003e\n\u003cp\u003e- Post marker Surveillance Plan (PMS) and PSUR\u003c\/p\u003e\n\u003cp\u003e- Stability Study\u003c\/p\u003e\n\u003cp\u003e- Etc. \u003c\/p\u003e\n\u003c\/div\u003e","brand":"My Store","offers":[{"title":"Default Title","offer_id":40689966809146,"sku":"","price":999.0,"currency_code":"AUD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0566\/2765\/8810\/files\/FullDocumantation-1a.jpg?v=1784723248","url":"https:\/\/documedex.com.au\/products\/full-technical-documentation","provider":"Documedex","version":"1.0","type":"link"}