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
• IDEs, HUDs
• Quality system certification
• Product certification
• Technical Files and Design Dossiers

Who Should Attend:

• Quality Assurance Departments
• Regulatory Affairs Departments
• Product Development Departments
• Device Manufacturing Departments

Course Director: CHARLES H. 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.