{"product_id":"iso-13485-iso-14971-integrated-compliance-pack","title":"ISO 13485 + ISO 14971 Integrated Compliance Pack","description":"\u003cp\u003eSeparate ISO 13485 and ISO 14971 implementations usually create duplicated records, broken traceability, and slow remediation when issues cross from design into post-market risk control. This integrated pack gives you a connected operating model so quality management and risk management reinforce each other instead of being maintained as parallel systems. 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\u003eIntegration Roadmap.pdf\u003c\/li\u003e\n\u003cli\u003eQMS Core Bundle.docx\/xlsx\u003c\/li\u003e\n\u003cli\u003eDesign Controls Execution System.docx\/xlsx\u003c\/li\u003e\n\u003cli\u003eRisk Management System.docx\/xlsx\u003c\/li\u003e\n\u003cli\u003eComplaint-CAPA-Risk Update Bridge Pack.pdf\u003c\/li\u003e\n\u003cli\u003eRole Specific Products \u0026gt; (Complaint\u003c\/li\u003e\n\u003cli\u003eManagement Review KPI Pack.xlsx\u003c\/li\u003e\n\u003c\/ul\u003e\u003cp\u003e\u003cstrong\u003eBest suited to:\u003c\/strong\u003e Startup manufacturer, Medical device manufacturer, Regulatory consultant, and Quality manager.\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 integrated QMS and risk management 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 integrated QMS and risk management.\u003c\/li\u003e\n\u003cli\u003eSupport EU MDR technical documentation or quality-system reviews where integrated QMS and risk management 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":47258390626498,"sku":"ISO 13485 + ISO 14971 Integrated Compliance Pack","price":1599.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0709\/8361\/4658\/files\/Firefly_GeminiFlash_Createasquarepremiumproductthumbnailfor_ISO13485_ISO14971IntegratedCompl74305.png?v=1773430643","url":"https:\/\/isocloudconsulting.com\/products\/iso-13485-iso-14971-integrated-compliance-pack","provider":"ISO Cloud Consulting","version":"1.0","type":"link"}