FDA and EU Medical Device Submissions

The basic requirements for medical device regulatory submissions are essentially the same between the FDA and EU while the individual country and region requirements for submission are somewhat different.

It is imperative to understand the similarities and differences when formulating a marketing strategy for the countries in which a medical device will be marketed.

This webinar will overview each critical aspect of the FDA submissions process to include 510(k) and PMA) and contrast those key steps to those of the EU Medical Device Directives Submissions process.

Areas Covered in the Session :
510(k) and PMA processes (US FDA)
Current EU Directives (MDD, AIMD, IVDD)
Intended use
Indications for use
Quality system certification
Product certification
Technical Files and Design Dossiers

Who Will Benefit:
Quality Assurance Departments
Regulatory Affairs Departments
Product Development Departments
Device Manufacturing Departments

Charles Paul

Charles Paul is an instructional designer and management consultant with over 30 years’ experience providing training and consulting services to regulated industries. He has installed quality systems and designed and developed GMP and operational documentation and training programs for foods and beverage, pharmaceuticals, biotech, cosmetics, and consumer product – OTC industries.

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  • Login Information with Password to join the session, 24 hours prior to the webinar
  • Presentation Handout in .pdf format
  • Presentation from the Speaker
  • Feedback form
  • Certificate of Attendance
  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance