{"product_id":"iso-13485-gap-assessment-starter-pack","title":"ISO 13485 Gap Assessment Starter Pack","description":"\u003cp\u003eCompanies starting or repairing an ISO 13485 system usually do not know which clauses are broken, which records are missing, or where to start first. This pack gives you a fast clause-by-clause baseline, a scoring method, and an action-plan structure so you can prioritize remediation before spending money on a full rebuild. That means less time spent rebuilding documents from scratch and a stronger line of evidence when the process is sampled under audit.\u003c\/p\u003e\u003ch3\u003eWhat's included\u003c\/h3\u003e\u003cul\u003e\n\u003cli\u003eISO 13485 Gap Assessment Workbook.xlsx\u003c\/li\u003e\n\u003cli\u003eFindings and Action Plan Template.docx\u003c\/li\u003e\n\u003cli\u003eAudit Readiness Checklist.pdf\u003c\/li\u003e\n\u003cli\u003eImplementation Guide.pdf\u003c\/li\u003e\n\u003c\/ul\u003e\u003cp\u003e\u003cstrong\u003eBest suited to:\u003c\/strong\u003e Startup manufacturer, Virtual manufacturer, Distributor, and Regulatory consultant.\u003c\/p\u003e\u003cp\u003e\u003cstrong\u003eUseful in audit situations where you need to:\u003c\/strong\u003e\u003c\/p\u003e\u003cul\u003e\n\u003cli\u003eShow a structured ISO 13485 gap assessment process during ISO 13485 certification, surveillance, supplier, or internal audits.\u003c\/li\u003e\n\u003cli\u003eSupport FDA inspections with controlled records, traceability, and process evidence related to ISO 13485 gap assessment.\u003c\/li\u003e\n\u003cli\u003eSupport EU MDR technical documentation or quality-system reviews where ISO 13485 gap assessment records need to be complete, controlled, and consistent.\u003c\/li\u003e\n\u003c\/ul\u003e\u003cp\u003eUse this pack to tighten execution, strengthen evidence, and make this part of your ISO 13485 system easier to defend under audit.\u003c\/p\u003e","brand":"ISO Cloud Consulting","offers":[{"title":"Default Title","offer_id":47258389840066,"sku":"ISO 13485 Gap Assessment Starter Pack","price":79.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0709\/8361\/4658\/files\/Firefly_Createasquarepremiumproductthumbnailfor_ISO13485GapAssessmentStarterPack_74305.png?v=1773430773","url":"https:\/\/isocloudconsulting.com\/products\/iso-13485-gap-assessment-starter-pack","provider":"ISO Cloud Consulting","version":"1.0","type":"link"}