The 8th Annual Medical Device Directives and The Revision 2014

Topics

• Requirements for Post Market Clinical Follow-Up (PMCFU) and impact on industry
• New role of the "Qualified Person" (QP) and how to practically prepare for this requirement
• Regulation of software as a medical device in light of the revision of the MDD
• Changes to the current system in the proposal for reprocessing of single-use medical devices
• Changes associated with the Eudamed database and impacts on industry
• MDR requirement for implant cards
• The revision of the In Vitro Diagnostic Directive (IVDD)

Who should Attend

• Quality Assurance
• Regulatory Affairs
• Clinical Research
• Clinical Affairs
• Compliance