A Comprehensive View of FDA Regulations for Medical Devices

The A Comprehensive View of FDA Regulations for Medical Devices is a seminar that covers topics such as:

  • The requirements to market a medical device in the US including device classification and conformity assessment paths
  • The law, regulations, and policies that FDA applies for medical device
  • How UDI will affect medical devices and how to prepare for implementation
  • The quality management systems that govern the design , manufacture, installation, and servicing of medical devices for the US market
  • Which devices must be tracked and how to set up and audit the system
  • The rules for Medical Device Reports (MDRs) and their relationship to complaints
  • The role of FDA Inspections, the use of QSIT, and the possible outcomes of an inspection
  • Correcting devices already shipped and when to report to FDA
  • The issues manufacturers face by reviewing Warning Letters related to the topics covered
  • Inspectional observations and how to respond to a Form 483

The A Comprehensive View of FDA Regulations for Medical Devices brings together attendees from medical device manufacturing companies:

  • Quality engineers
  • Quality managers
  • Regulatory affairs managers
  • Quality assurance and quality control
  • R&D managers
  • Regulatory affairs professionals
  • Product design and development
  • R&D engineers
  • Production managers and supervisors
  • Operations managers
  • Risk managers
  • Manufacturing engineers
  • CAPA team members
  • Complaint system team members
  • Device marketing personnel


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

Prices are for evaluation only.

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