{"product_id":"medical-device-adverse-event-reporting-template-qmsr-fda-mdr-compliant","title":"Medical Device Adverse Event Reporting Template – QMSR Compatible","description":"\u003ch2\u003eQMSR Compatible Adverse Event Reporting Procedure Template\u003c\/h2\u003e\u003cp\u003eWhen a serious injury or device malfunction occurs, your team needs to act fast — and your documentation needs to be airtight. This Adverse Event Reporting template gives medical device manufacturers a structured, audit-ready procedure compatible with QMSR (21 CFR Part 820) and FDA Medical Device Reporting (MDR) requirements under 21 CFR Part 803.\u003c\/p\u003e\u003ch3\u003eWhat's Included\u003c\/h3\u003e\u003cul\u003e\n\u003cli\u003eComplete Adverse Event Reporting procedure compatible with QMSR and 21 CFR Part 803\u003c\/li\u003e\n\u003cli\u003eMDR decision tree for determining reportability\u003c\/li\u003e\n\u003cli\u003eComplaint and event intake form templates\u003c\/li\u003e\n\u003cli\u003eRoles and responsibilities matrix\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 manufacturers subject to FDA MDR requirements\u003c\/li\u003e\n\u003cli\u003eQuality and regulatory affairs teams managing post-market surveillance\u003c\/li\u003e\n\u003cli\u003eStartups preparing for FDA registration and first inspections\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":51160435851497,"sku":null,"price":197.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0813\/9243\/5433\/files\/AdverseEvent.png?v=1781056291","url":"https:\/\/sonicqualitytemplates.com\/products\/medical-device-adverse-event-reporting-template-qmsr-fda-mdr-compliant","provider":"Sonic Quality Templates","version":"1.0","type":"link"}