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Drug Device Combination Products

Tackle unique combination products challenges under the EU MDR: Classification, Implementation & Strategy

Highlights Include:

Answering your burning questions…
  • What are Competent Authority perspectives on the combination products regulatory landscape?
  • How are Notified Bodies interpreting Article 117 and how should manufacturers prepare?
  • How has the MDR impacted borderline products and what is required from industry?
  • What are the guidelines for combination products across the life-cycle?

Competent Authority and Notified Body perspectives from…
  • FAHMP
  • FDA
  • TÜV SÜD

Discuss, debate and analyse the big issues...
  • Regulatory expectations and common pitfalls during the registration process
  • Combination product classifications and regulations in global markets
  • Creating an effective end-to-end quality management system for combination products
  • Biocompatibility for combination products

Free On-Demand Content

Webinars. Webinars. Webinars.

Latest status and practical experience of implementing the new EU MDR

Speaker:
Bassil Akra, Vice President, Global Focus Teams (Cardiovascular, Orthopeadic and Clinical), TÜV SÜD Product Service GmbH, Germany
WATCH THIS WEBINAR