{"title":"ISO 13485 Templates","description":"","products":[{"product_id":"iso-14971-risk-management-sop-templates-medical-device","title":"ISO 14971 Risk Management SOP Templates - Complete Medical Device Risk Assessment Package","description":"\u003cp class=\"whitespace-normal break-words\"\u003e\u003cstrong\u003eTransform Medical Device Risk Management Into FDA Compliance Success\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp class=\"whitespace-normal break-words\"\u003eDownload instantly: Professional ISO 14971:2019 risk management SOP templates used by successful medical device manufacturers nationwide.\u003c\/p\u003e\n\u003cp class=\"whitespace-normal break-words\"\u003e\u003cstrong\u003eComplete Risk Management Template Package:\u003c\/strong\u003e\u003c\/p\u003e\n\u003cul class=\"[\u0026amp;:not(:last-child)_ul]:pb-1 [\u0026amp;:not(:last-child)_ol]:pb-1 list-disc space-y-1.5 pl-7\"\u003e\n\u003cli class=\"whitespace-normal break-words\"\u003eISO 14971 Risk Management SOP with implementation workflows\u003c\/li\u003e\n\u003cli class=\"whitespace-normal break-words\"\u003eRisk Management Plan and Report templates\u003c\/li\u003e\n\u003cli class=\"whitespace-normal break-words\"\u003eCustomizable risk assessment matrices (3x3, 4x4, 5x5)\u003c\/li\u003e\n\u003cli class=\"whitespace-normal break-words\"\u003eMedical device risk control procedures\u003c\/li\u003e\n\u003cli class=\"whitespace-normal break-words\"\u003eQQS SOP template for unlimited additional procedures\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp class=\"whitespace-normal break-words\"\u003e\u003cstrong\u003eProven Business Results:\u003c\/strong\u003e\u003c\/p\u003e\n\u003cul\u003e\n\u003cli\u003eCut design control costs by identifying risks early\u003c\/li\u003e\n\u003cli\u003eAccelerate FDA submissions with complete risk file\u003c\/li\u003e\n\u003cli\u003eReduce product liability through systematic analysis\u003c\/li\u003e\n\u003cli\u003eSave $15,000+ vs hiring quality consultants\u003cbr\u003e\n\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp class=\"whitespace-normal break-words\"\u003e\u003cstrong\u003eFDA \u0026amp; ISO Compliance Standards:\u003c\/strong\u003e ISO 14971:2019 Medical Device Risk Management | FDA 21 CFR Part 820 Design Controls | EU MDR Article 10 | QMSR 2026 Ready\u003c\/p\u003e\n\u003cp class=\"whitespace-normal break-words\"\u003e\u003cstrong\u003ePerfect for:\u003c\/strong\u003e Medical device startups, quality managers preparing for FDA inspection, ISO 13485 implementation, device manufacturers, regulatory consultants\u003c\/p\u003e\n\u003cp class=\"whitespace-normal break-words\"\u003e\u003cem\u003eField-tested across Class I-III medical devices. Instant download - be compliant within 30 days.\u003c\/em\u003e\u003c\/p\u003e\n\u003cp class=\"whitespace-normal break-words\"\u003e\u003cstrong\u003eWhy Medical Device Companies Choose These Risk Management Templates\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp class=\"whitespace-normal break-words\"\u003eThese professional risk management SOP templates eliminate the guesswork from ISO 14971 compliance. Created by a 10+ year cGMP specialist, each template includes step-by-step procedures that satisfy FDA inspectors and ISO auditors.\u003c\/p\u003e\n\u003cp class=\"whitespace-normal break-words\"\u003e\u003cstrong\u003eCommon Risk Management Challenges Solved:\u003c\/strong\u003e\u003c\/p\u003e\n\u003cul class=\"[\u0026amp;:not(:last-child)_ul]:pb-1 [\u0026amp;:not(:last-child)_ol]:pb-1 list-disc space-y-1.5 pl-7\"\u003e\n\u003cli class=\"whitespace-normal break-words\"\u003eHow to create compliant risk assessment matrices\u003c\/li\u003e\n\u003cli class=\"whitespace-normal break-words\"\u003eFDA Design Controls integration requirements\u003c\/li\u003e\n\u003cli class=\"whitespace-normal break-words\"\u003eISO 14971:2019 vs previous version differences\u003c\/li\u003e\n\u003cli class=\"whitespace-normal break-words\"\u003eRisk control prioritization and documentation\u003c\/li\u003e\n\u003cli class=\"whitespace-normal break-words\"\u003ePost-market surveillance integration\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp class=\"whitespace-normal break-words\"\u003e\u003cstrong\u003eDownload Includes Complete Documentation:\u003c\/strong\u003e Your risk management template package provides everything needed for immediate implementation, including forms, procedures, and implementation guidance that works for medical device companies of any size.\u003c\/p\u003e","brand":"Quantum Quality Systems","offers":[{"title":"Default Title","offer_id":50463609225496,"sku":null,"price":89.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0940\/0021\/8392\/files\/WhiteMinimalistPosterMockupsInstagramPost.png?v=1752537574"},{"product_id":"free-medical-device-gdp-sop-sample","title":"FREE Medical Device GDP SOP Sample - 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Download instantly - stop recurring problems within 45 days.\u003c\/em\u003e\u003c\/p\u003e\n\u003cp class=\"whitespace-normal break-words\"\u003e\u003cstrong\u003eMedical Device CAPA Best Practices and Templates\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp class=\"whitespace-normal break-words\"\u003eEffective CAPA systems require systematic approaches that satisfy FDA 21 CFR Part 820.100 requirements while actually preventing problem recurrence. 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