A Comprehensive View of FDA Regulations for Medical Devices 2017

Key Topics

• 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

Who should Attend

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