Compliance Trainings, Online
2015-06-10
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 made Overview of European Medical Device Regulations and Regulatory Framework for Medical Devices CE Marking Principles Device Classification Medical Device Directive (MDD) In Vitro Diagnostic Device Directive (IV(M)DD) Active Implantable Medical Device Directive (AIMDD) 2007/47/EC Amending MDD and AIMDD Globally Harmonized Technical File And Design Dossier Declaration of Conformity Clinical Evaluation Postmarket Requirements: Surveillance and Vigilance Harmonized Standards EN ISO 14971:2012, EN ISO 13485:2012, and ISO 14155 IMDRF MEDDEV Guidance Documents Update on the EU Regulatory Scheme Good Practices Speaker’s PASS-IT Suggestion/Recommendations Conclusion Who Will Benefit: CEOs VPs Compliance Officers Attorneys Complainant Managers Managers (RA, QA/QC, CA) Consultants Contractors and Subcontractors Price tags: Live Single Live : For One Participant $ 249 Corporate Live : For Max. 10 Participants $ 899 Recording Single REC : For One Participant - Unlimited Access for 6 Months $ 299 For more information and enquiries contact us at Compliance Trainings 5939 Candlebrook Ct, Mississauga, ON L5V 2V5, Canada
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Email : support@compliancetrainings.com
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