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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…
  • FDA

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

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