BEGIN:VCALENDAR PRODID:-//github.com/rianjs/ical.net//NONSGML ical.net 4.0//EN VERSION:2.0 BEGIN:VEVENT DESCRIPTION:This webinar will discuss the main regulatory regimes for  \;medical devices in US\, Canada\, Brazil\, Japan and Australia\, how the y differ from EU CE mark regulations and how to address compliance though a \;Medical Device Single Audit Program (MDSAP) \;and ISO 13486: 2016 approach\n\nDescription:\n\nThe webinar will discuss in detail how t o address the gaps between US\, Canada\, Brazil\, Japan\, Australia and E U ISO 13485:2016 requirements for:\n\n\nManagement responsibilities\nDevi ce marketing authorization\nFacility registration\nMeasurement\, analysis &\; improvement\nAdverse events &\; vigilance reporting\nDesign an d development\nManufacturing and service controls\nPurchasing activities\ n\nWhy Should You Attend:\n\nCompanies conducting business in various geo graphical regions have to address numerous specific regulatory requiremen ts from each of those geographies. This webinar will provide practical to ols to address specific requirements from US\, Canada\, Brazil\, Japan\, Australia and EU ISO 13485:2016 requirements from an unique Quality Manag ement System (QMS) architecture ensuring compliance with those regulation s\n\nAreas Covered in the Webinar:\n\n\nManagement responsibilities\nDevi ce marketing authorization\nFacility registration\nMeasurement\, analysis &\; improvement\nAdverse events &\; vigilance reporting\nDesign an d development\nManufacturing and service controls\nPurchasing activities\ n\nWho Will Benefit:\n\n\nQuality Assurance Managers / Directors / VPs\nR egulatory Compliance Managers / Directors /VPs\nRegulatory Affairs Manage rs / Directors / VPs\nClinical Managers / Directors / VPs\n\nMedical Devi ce industries conducting or planning to conduct business in the European Union\n DTEND:20250220T100000 DTSTAMP:20260512T231938Z DTSTART:20250220T090000 LOCATION:\, SEQUENCE:0 SUMMARY:This webinar will discuss the main regulatory regimes for \;me dical devices in US\, Canada\, Brazil\, Japan and Australia\, how they di ffer from EU... UID:a329d9b5-e2f5-414a-8a58-07e17a8634ed END:VEVENT END:VCALENDAR