Join Christie Hughes for a RAPS Workshop | US Regulatory Essentials, Devices

May 05, 2021 - May 06, 2021 / Global

Date: May 5th & 6th, 2021

Time: 10:30am -3:30pm ET

Location: Virtual

Language: English


Gain a thorough understanding of regulatory affairs for medical devices and IVDs in the U.S. in this intensive, two-day online workshop. Regulatory experts will discuss the laws, regulations, and enforcement and agency structures regulating devices and IVD products. They will review advertising, labeling and promotion post-market, as well as compliance and enforcement requirements. The speakers will also cover FDA guidance, and options and strategies for FDA submissions.


Pricing Amounts & Deadlines

10 November 2020 – 4 April 2021: Early Bird $800.00 Member | $900.00 Nonmember

5 April – 28 April 2021: Regular $900.00 Member | $1000.00 Nonmember


Who Should Attend?

This workshop will benefit individuals who are new to the regulatory profession, entering the medical device industry, or changing companies and/or product lines or industry. The material will also be helpful to anyone studying for the RAC Devices exam.


    Workshop Overview
  • FDA history
  • FDA organization
  • DICE role
    Overview of Medical Devices and IVDS
  • Classification
  • 513(g) and de novo
  • PMA perspectives
  • 510(k) perspectives
  • IDE and HDE perspectives
  • Clinical conduct perspectives

         QSR/QMS and Design Control

  • Medical device
  • IVD Breakout
  • Postmarket Compliance is No Easy Journey
  • Complaint handling and management
  • Understanding medical device reporting
  • Corrections/Removals (recalls)
  • Navigating an FDA Inspection and Aftermath
  • The knock on the door
  • Conduction inspection
  • Close-out meeting
  • Post-inspection and enforcement
  • Advertising, Promotion and Labeling
  • Label and labeling
  • Claims substantiation
  • Lessons learned from warning letters
  • Disseminating information about unapproved devices
  • Intended vs. off-label use
  • Direct-to-consumer advertising
  • Social media
Christie Hughes
Post date: April 28, 2021
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