2014 - Best Practices for Preparing for a Technical File for CE Mark

DESCRIPTION
This webinar is intended to help you get familiar with how to prepare for a technical file and submit it to a notified body for CE marking purposes under directives governing medical devices: medical devices including in vitro diagnostic and active implantable medical devices. This webinar is further intended to provide guidance on the regulatory requirements set out in the applicable Directives, which help assure that medical devices are safe and effective for their intended use.
Understanding the EU regulatory and quality requirements can significantly contribute to meeting the requirements and achieving compliance fast, resulting in saving significant amount of time and efforts and bringing innovative medical products to the EU market faster.
This webinar will discuss EU directives and contents and format for a technical file. At the end of the webinar, you will have a great opportunity to improve your way of preparing for and managing your technical file for CE mark purposes.
Why should you attend :
This webinar is intended to help you get familiar with how to put together a technical file for CE mark in the European Union (EU) in accordance with three directives governing medical devices including in vitro diagnostic and active implantable medical devices.
Areas Covered in the Session:
How EU laws are made
Overview of EU Directives
Medical Device Directive (MDD)
Active Implantable Medical Device Directive (AIMDD)
In Vitro Diagnostic Device Directive (IVDD
2007/47/EC Amending MDD and AIMDD
CE Marking Principles
Device Classification
Contents and Format for a Technical File And Design Dossier
Content of Declaration of Conformity
Clinical Evaluation
Overview of ISO 13485, ISO 14155, And ISO 14971
GHTF/IMDRF and MEDDEV Guidance Documents
PASS-IT Recommendations/Suggestions
Who will benefit: (Titles)
CEOs
VPs
Compliance officers
Attorneys
Clinical affairs (associates, specialists, managers, directors or VPs)
Regulatory affairs (associates, specialists, managers, directors or VPs)
Quality assurance (associates, specialists, managers, directors or VPs)
R&D (engineers, scientists, managers, directors or VPs)
CROs
Consultants
Contractors/subcontractors
Webinar Includes:
Q/A Session with the Expert to ask your question
PDF print only copy of PowerPoint slides
60 Minutes Live Presentation
Certificate of Attendance