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EU Medical Device Regulation: Top Challenges of Orthopedic Manufacturers

Two-part MDR Series: Stay for One, or Both

When: Tuesday, June 11 | 3:00 pm - 4:00 pm 
Where: Room 49 - Product Lifecycle Management Track
Level: Intermediate, Advanced
Participant Type: Research & Development, Product Development, Regulatory/Clinical Affairs, Sales & Marketing, Supply Chain Management, Quality Control

 

Description

In light of the looming May 2020 compliance deadline for the EU Medical Device Regulation (MDR), TÜV SÜD will review the regulation’s core changes, share the main challenges that orthopedic device manufacturers face and leave adequate time for you to pose questions to a Notified Body. MDR is expected to have a significant impact within multiple departments of device companies. This session is intended to provide answers to your pressing questions and a checklist of actions to take in the final months of the transition period.

Attendee Takeaways

  • Receive a brief overview of the main differences between MDD and MDR
  • Understand spinal device reclassification
  • Learn changes to sterile instruments
  • Receive clarification on when to add a mark to implants and instruments
  • Review main challenges that orthopedic manufacturers face and receive guidance

Speakers

Max Singh, Ph.D., is the Global Director of the Orthopedic Focus Team at TÜV SÜD Product Service. Prior to this role, he spent 15 years in the medical device industry working for KARL STORZ, Stryker and ulrich medical. Dr. Singh held several positions in R&D, where he was in charge of designing medical devices and gained experience with computer-assisted surgery and surgical robotics. In addition to R&D, Dr. Singh was responsible for product management and marketing of product portfolios. Dr. Singh holds academic degrees in medical engineering and business administration. For his doctoral research, he investigated various aspects of spine surgery technologies in the U.S. medical device industry.

 

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