Description :This presentation is intended to help you get familiar with the European Union (EU) Directives governing medical devices including in vitro diagnostic and active implantable medical devices. This presentation is further intended to provide practical, actionable, and sustainable guidance on the regulatory requirements set out in the three directives (MDD, IV(M)DD, and AIMDD).Understanding and accurate interpretation of the EU regulatory and quality requirements can significantly contribute to meeting the requirements and achieving compliance fast, leading to saving an enormous amount of your time, efforts and resources and resulting in bringing innovative medical products to the EU market faster. This presentation will offer you great opportunities to learn about three directives (MDD, IVDD and AIMDD) and regulatory requirements including postmarket requirements and compliance.  At the end of the presentation, you will get familiarized with the applicable EU directives governing medical devices including in-vitro diagnostic and active implantable medical devices, helping you implement regulatory requirements smooth and fast.Areas Covered in the Session :How EU laws are madeOverview of European Medical Device Regulations and Regulatory Framework for Medical DevicesCE Marking PrinciplesDevice ClassificationMedical Device Directive (MDD)In Vitro Diagnostic Device Directive (IV(M)DD)Active Implantable Medical Device Directive (AIMDD)2007/47/EC Amending MDD and AIMDDGlobally Harmonized Technical File And Design DossierDeclaration of ConformityClinical EvaluationPostmarket Requirements: Surveillance and VigilanceHarmonized StandardsEN ISO 14971:2012, EN ISO 13485:2012, and ISO 14155IMDRFMEDDEV Guidance DocumentsUpdate on the EU Regulatory SchemeGood PracticesSpeaker’s PASS-IT Suggestion/RecommendationsConclusionWho Will Benefit:CEOsVPsCompliance OfficersAttorneysComplainant ManagersManagers (RA, QA/QC, CA)ConsultantsContractors and SubcontractorsPrice tags:LiveSingle Live : For One Participant$ 249Corporate Live : For Max. 10 Participants$ 899RecordingSingle REC : For One Participant - Unlimited Access for 6 Months$ 299For more information and enquiries contact us atCompliance Trainings5939 Candlebrook Ct, Mississauga, ON L5V 2V5, Canada  Customer Support : #416-915-4458