Clinical Evaluation Reports (CER`s) Required for All Medical Devices in Europe 2016

Topics

• Prepare and execute a literature review
• The Essential Requirements and the relationship to the CER
• Construct and manage the Technical File
• The elements comprising the CER and recommended format
• What resources exist to guide you in developing a clinical evaluation report , including how to select a format for writing it and keeping it updated
• The expectation that devices sold in Europe must have a CER in it`s Tech File unless you justify otherwise

Who should Attend

Attendees from:

• Regulatory Affairs Management and RA Specialists
• QA/Compliance
• Consultants
• Marketing
• Clinical Affairs