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DTSTART:19700308T020000
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UID:2140535:Event:66207
DTSTAMP:20260521T134345Z
SUMMARY:Webinar On CE Mark: Content and Format for a Technical File an
 d Design Dossier
DESCRIPTION:Description :\nThis presentation is intended to help you g
 et familiar with the European Union (EU) Directives governing medical 
 devices including in vitro diagnostic and active implantable medical d
 evices. \nThis presentation is further intended to provide practical,
  actionable, and sustainable guidance on the regulatory requirements s
 et out in the three directives (MDD, IV(M)DD, and AIMDD).\nUnderstandi
 ng and accurate interpretation of the EU regulatory and quality requir
 ements can significantly contribute to meeting the requirements and ac
 hieving compliance fast, leading to saving an enormous amount of your 
 time, efforts and resources and resulting in bringing innovative medic
 al products to the EU market faster. \nThis presentation will offer y
 ou great opportunities to learn about three directives (MDD, IVDD and 
 AIMDD) and regulatory requirements including postmarket requirements a
 nd compliance.  At the end of the presentation, you will get familiar
 ized with the applicable EU directives governing medical devices inclu
 ding in-vitro diagnostic and active implantable medical devices, helpi
 ng you implement regulatory requirements smooth and fast.\nAreas Cover
 ed in the Session :\nHow EU laws are made\nOverview of European Medica
 l Device Regulations and Regulatory Framework for Medical Devices\nCE 
 Marking Principles\nDevice Classification\nMedical Device Directive (M
 DD)\nIn Vitro Diagnostic Device Directive (IV(M)DD)\nActive Implantabl
 e Medical Device Directive (AIMDD)\n2007/47/EC Amending MDD and AIMDD\
 nGlobally Harmonized Technical File And Design Dossier\nDeclaration of
  Conformity\nClinical Evaluation\nPostmarket Requirements: Surveillanc
 e and Vigilance\nHarmonized Standards\nEN ISO 14971:2012, EN ISO 13485
 :2012, and ISO 14155\nIMDRF\nMEDDEV Guidance Documents\nUpdate on the 
 EU Regulatory Scheme\nGood Practices\nSpeaker’s PASS-IT Suggestion/R
 ecommendations\nConclusion\nWho Will Benefit:\nCEOs\nVPs\nCompliance O
 fficers\nAttorneys\nComplainant Managers\nManagers (RA, QA/QC, CA)\nCo
 nsultants\nContractors and Subcontractors\nPrice tags:\nLive\nSingle L
 ive : For One Participant\n$ 249\nCorporate Live : For Max. 10 Partici
 pants\n$ 899\nRecording\nSingle REC : For One Participant - Unlimited 
 Access for 6 Months\n$ 299\nFor more information and enquiries contact
  us at\nCompliance Trainings\n5939 Candlebrook Ct, Mississauga, ON L5
 V 2V5, Canada  Customer Support : #416-915-4458  Email : support@c
 ompliancetrainings.com\n\nFor more information visit https://medtechiq
 .ning.com/events/webinar-on-ce-mark-content-and-format-for-a-technical
 -file-and
DTSTART;TZID=America/New_York:20150610T130000
DTEND;TZID=America/New_York:20150610T140000
CATEGORIES:webinar
LOCATION:Online
WEBSITE:https://compliancetrainings.com/SiteEngine/ProductDetailView.a
 spx?id=MD1516
URL:https://compliancetrainings.com/SiteEngine/ProductDetailView.aspx?
 id=MD1516
CONTACT:4169154458
ORGANIZER:Compliance Trainings
ATTACH;FMTTYPE="image/jpeg":
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN=complianc
 etrainings:https://medtechiq.ning.com/profile/compliancetrainings
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