Learning Marketplace

Basic Anatomy of a Design Dossier

Is your product considered a high-risk Class III medical device in Europe? If so, you will need to compile a Design Dossier for review by a Notified Body to demonstrate how your product meets the Essential Requirements of the appropriate Directive.

BSI's FREE webinar outlines the key elements that are necessary for you to include in your submission for EU approval. BSI has helped thousands of companies navigate the regulatory path to achieve CE Marking and entrance into the European Market. Register today and learn from BSI's medical device expertise!

Learning Objectives

  • Understand the EU requirements for technical documentation
  • Know when a Design Dossier is required
  • Distinguish among the key elements of this specialized technical documentation
  • Recognize how an incomplete or poorly organized Design Dossier can negatively impact on reviews
  • Become familiar with BSI "speed-to-market" service options

Who Should Attend

  • Manufacturers of class III medical devices
  • Regulatory Affairs professionals
  • Quality Assurance professionals
  • Medical Device Design Engineers
  • Medical Device Marketing Managers
  • Medical Device Consultants