Understanding and Implementing the Medical Device Directive

The Understanding and Implementing the Medical Device Directive is a seminar that covers topics such as:

  • Integrate the Clinical Evaluation in the MDD into the essential requirements and risk management processes
  • The MDD Essential Requirements and document compliance
  • Prepare for Unannounced Inspections
  • The conformity assessment paths and how they apply to particular devices
  • The role of the harmonized standards in demonstrating the Essential Requirements
  • The role of EN ISO 13485:2012 and its relationship to conformity assessment
  • The medical device classification system and how to apply it
  • The requirements for Risk Management and the use of EN ISO 14971:2012
  • The role of product directives in the EU
  • The vigilance system including reporting, Field Safety Corrective Action, and Field Safety Notice

The Understanding and Implementing the Medical Device Directive brings together:

  • Clinical Managers
  • Regulatory Managers
  • Quality Managers and Directors
  • Export Compliance Managers
  • Marketing Managers

Important

Please, check the official conference website for possible changes, before you make any traveling arrangements

Prices are for evaluation only.

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