Best Practices for Preparing for a Technical File for CE Mark 2015
20 May 2015
Webinar
Description
Topics
Overview of EU Directives
How EU laws are made
Active Implantable Medical Device Directive (AIMDD)
Medical Device Directive (MDD)
2007/47/EC Amending MDD and AIMDD
In Vitro Diagnostic Device Directive (IVDD
Device Classification
CE Marking Principles
Content of Declaration of Conformity
Contents and Format for a Technical File And Design Dossier
Overview of ISO 13485, ISO 14155, And ISO 14971
Clinical Evaluation
PASS-IT Recommendations/Suggestions
GHTF/IMDRF and MEDDEV Guidance Documents
Who should Attend
VPs
CEOs
Attorneys
Compliance officers
Regulatory affairs (associates, specialists, managers, directors or VPs)
Clinical affairs (associates, specialists, managers, directors or VPs)
R&D (engineers, scientists, managers, directors or VPs)
Quality assurance (associates, specialists, managers, directors or VPs)
Consultants
CROs
Contractors/subcontractors
Past Events
Best Practices for Preparing for a Technical File for CE Mark 2015 - 20 May 2015, Webinar (47303)
Important
Please, check "Best Practices for Preparing for a Technical File for CE Mark" official website for possible changes, before making any traveling arrangements
