How to prepare a 510(k) Notification and a Technical File for the CE Mark 2017

Topics

• Technical File
  • Determine Device Classification and Conformity Assessment Procedure
  • Formatting a Technical File
  • Clinical Evaluation Report Requirements
  • Essential Requirements Checklist Requirements
  • Contents of a Declaration of Conformity
  • Risk Management Plan and Reports Requirements
  • Key changes in the new Medical Device Directive
• 510(k) Notifications
  • When to file for a new device, a change in the intended use or a change in the technology of a cleared device
  • Difference between a traditional, abbreviated and special 510(k) and when to submit each type of 510(k)
  • What is substantial equivalence and what`s required to show substantial equivalence
  • What is contained in a traditional, abbreviated and special 510(k) submission package
  • Which performance tests should be conducted and how to present the data to the FDA
  • What`s required on the labeling and IFU
  • What is required in a submission for software controlled devices
  • Understand the FDA`s Refuse to Accept Policy

Who should Attend

• Regulatory Affairs Managers
• Company CEOs and Presidents
• Regulatory and Quality Assurance Professionals
• Quality Assurance Managers
• Quality Engineers
• Design Engineers
• Legal Professionals