{"product_id":"pms-and-vigilance-system-pms-fsca-and-fsn","title":"PMS \u0026 Vigilance System (PMS, FSCA \u0026 FSN)","description":"\u003cp\u003ePost-market surveillance often becomes reactive, with complaint data, vigilance decisions, and field actions spread across disconnected logs and email threads. This system gives you a usable post-market structure for planning, trending, escalation, field actions, and regulatory response documentation. 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\u003ePMS Plan.docx\u003c\/li\u003e\n\u003cli\u003ePMS Report Template.docx\u003c\/li\u003e\n\u003cli\u003eField Safety Corrective Action SOP.docx\u003c\/li\u003e\n\u003cli\u003eField Safety Notice Template.docx\u003c\/li\u003e\n\u003cli\u003eFSCA Response Form Template.docx\u003c\/li\u003e\n\u003cli\u003eIncident Report Register.xlsx\u003c\/li\u003e\n\u003cli\u003eComplaint Trend Sheet.xlsx\u003c\/li\u003e\n\u003cli\u003eSignal Review Workbook.xlsx\u003c\/li\u003e\n\u003cli\u003eImplementation Guide.pdf\u003c\/li\u003e\n\u003c\/ul\u003e\u003cp\u003e\u003cstrong\u003eBest suited to:\u003c\/strong\u003e Quality manager, Regulatory affairs, Distributor, and Manufacturer.\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 post-market surveillance and vigilance 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 post-market surveillance and vigilance.\u003c\/li\u003e\n\u003cli\u003eSupport EU MDR technical documentation or quality-system reviews where post-market surveillance and vigilance records need to be complete, controlled, and consistent.\u003c\/li\u003e\n\u003c\/ul\u003e\u003cp\u003eUse this system to move faster, create cleaner evidence, and reduce the time it takes to stand up or repair this part of your ISO 13485 framework.\u003c\/p\u003e","brand":"ISO Cloud Consulting","offers":[{"title":"Default Title","offer_id":47258390560962,"sku":"PMS \u0026 Vigilance System (PMS, FSCA \u0026 FSN)","price":499.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0709\/8361\/4658\/files\/Firefly_Createasquarepremiumproductthumbnailfor_PMS_VigilanceSystem_PMS_FSCA_FS74305.png?v=1773431293","url":"https:\/\/isocloudconsulting.com\/products\/pms-and-vigilance-system-pms-fsca-and-fsn","provider":"ISO Cloud Consulting","version":"1.0","type":"link"}