{"product_id":"iso-13485-complaint-handling-pms-vigilance-kit","title":"ISO 13485 Complaint Handling, PMS \u0026 Vigilance Kit","description":"\u003cp\u003eFrom the first customer call to a regulator report: complaint handling, reportability decisions for FDA and EU MDR, post-market surveillance, field safety corrective actions and advisory notices, plus a worked example that links a complaint to CAPA and the risk file.\u003c\/p\u003e\u003ch2\u003eWhat's inside (29 files)\u003c\/h2\u003e\u003cul\u003e\n\u003cli\u003e\n\u003cstrong\u003eComplaint Handling:\u003c\/strong\u003e Complaint Trend Sheet; Complaint and Feedback Form; Complaint and Feedback Handling SOP.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eRegulatory Reporting:\u003c\/strong\u003e Regulatory Reporting SOP - Generic; Regulatory Reporting SOP - US FDA (MDR); Vigilance Reporting SOP - EU MDR.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003ePost-Market Surveillance:\u003c\/strong\u003e PMS Data Sources and Signal Review; PMS Plan; PMS Report; Post-Market Surveillance Procedure.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eField Actions and Advisory Notices:\u003c\/strong\u003e Advisory Notice - EU MDR; Advisory Notice - ISO 13485; FSCA Customer Response Form; Field Action Notice - US FDA; Field Safety Corrective Action SOP; Field Safety Notice.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eComplaint to CAPA to Risk Worked Example:\u003c\/strong\u003e Complaint to CAPA to Risk - Filled Example; Complaint to CAPA to Risk - Operating Manual; Complaint to CAPA to Risk - Record Templates; Complaint to CAPA to Risk - Tools Workbook.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eTraining:\u003c\/strong\u003e Complaint Handling training module (slides, trainer guide, workbook, assessment); PMS and Vigilance training module (slides, trainer guide, workbook, assessment).\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch2\u003eHow to use it\u003c\/h2\u003e\u003col\u003e\n\u003cli\u003eAdapt the complaint SOP and form; decide who evaluates complaints and how fast.\u003c\/li\u003e\n\u003cli\u003eChoose the reporting SOP for your markets (US FDA MDR, EU MDR or generic) and set reportability decision rules.\u003c\/li\u003e\n\u003cli\u003eWrite the PMS plan and feed complaint trends and other data into it.\u003c\/li\u003e\n\u003cli\u003eKeep the FSCA SOP and notice templates ready so an advisory notice can be issued at any time.\u003c\/li\u003e\n\u003cli\u003eWalk through the worked example to see one complaint flow into CAPA and a risk file update.\u003c\/li\u003e\n\u003c\/ol\u003e\u003ch2\u003eWho it's for\u003c\/h2\u003e\u003cp\u003eManufacturers, importers and distributors who handle complaints, reportable events and field actions.\u003c\/p\u003e\u003ch2\u003eGood to know\u003c\/h2\u003e\u003cul\u003e\n\u003cli\u003eInstant download. Editable Microsoft Office files, no macros.\u003c\/li\u003e\n\u003cli\u003eIncludes a Start Here guide with the contents and how to use them.\u003c\/li\u003e\n\u003cli\u003eLicensed for one organization, including its sites.\u003c\/li\u003e\n\u003cli\u003eTemplates don't reproduce ISO standards. You need your own licensed copies.\u003c\/li\u003e\n\u003cli\u003eAlso in the \u003ca href=\"\/products\/iso-13485-complete-qms-kit\"\u003eISO 13485 Complete QMS Kit\u003c\/a\u003e, which costs less than buying kits separately.\u003c\/li\u003e\n\u003c\/ul\u003e","brand":"ISO Cloud Consulting","offers":[{"title":"Default Title","offer_id":50498917368002,"sku":"ICC-13485-PMS","price":99.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0709\/8361\/4658\/files\/iso-13485-complaint-handling-pms-vigilance-kit.png?v=1790150890","url":"https:\/\/isocloudconsulting.com\/products\/iso-13485-complaint-handling-pms-vigilance-kit","provider":"ISO Cloud Consulting","version":"1.0","type":"link"}