2015 - Webinar On CE Mark: Content and Format for a Technical File and Design Dossier

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
Customer Support : #416-915-4458
Email : support-AT-compliancetrainings.com