{"product_id":"medical-device-quality-system-template-for-qmsr-quality-manual","title":"Medical Device Quality Manual Template – QMSR Compatible","description":"\u003ch2\u003eQMSR Compatible Quality Manual Template\u003c\/h2\u003e\u003cp\u003eStay ahead of FDA compliance with this comprehensive Quality Manual template, purpose-built for medical device manufacturers navigating the Quality Management System Regulation (QMSR, 21 CFR Part 820).\u003c\/p\u003e\u003cp\u003eWhether you're a startup preparing for your first FDA inspection or an established manufacturer updating your QMS to align with ISO 13485:2016, this template gives you a proven, audit-ready framework — without starting from scratch.\u003c\/p\u003e\u003ch3\u003eWhat's Included\u003c\/h3\u003e\u003cul\u003e\n\u003cli\u003eComplete Quality Manual structure compatible with QMSR and ISO 13485:2016\u003c\/li\u003e\n\u003cli\u003ePre-written policy statements and section templates\u003c\/li\u003e\n\u003cli\u003eScope, exclusions, and normative references guidance\u003c\/li\u003e\n\u003cli\u003eManagement responsibility and quality planning sections\u003c\/li\u003e\n\u003cli\u003eEditable in Microsoft Word and Google Docs\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch3\u003eWho This Is For\u003c\/h3\u003e\u003cul\u003e\n\u003cli\u003eMedical device startups building their QMS from the ground up\u003c\/li\u003e\n\u003cli\u003eRegulatory affairs and quality managers updating legacy systems\u003c\/li\u003e\n\u003cli\u003eConsultants supporting FDA submissions and audits\u003c\/li\u003e\n\u003c\/ul\u003e\u003cp\u003e\u003cstrong\u003eInstant digital download.\u003c\/strong\u003e No shipping required.\u003c\/p\u003e","brand":"Sonic Quality Templates","offers":[{"title":"Default Title","offer_id":51160429330665,"sku":null,"price":197.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0813\/9243\/5433\/files\/QualityManual_8805f2e1-ea30-4302-91f3-70739bca2db8.png?v=1781108036","url":"https:\/\/sonicqualitytemplates.com\/products\/medical-device-quality-system-template-for-qmsr-quality-manual","provider":"Sonic Quality Templates","version":"1.0","type":"link"}