The EU Medical Device Regulation (MDR) has presented unique challenges for orthopedic device manufacturers and regulators alike. Gaining clarity on the regulation’s new requirements and ensuring compliant business processes have required significant planning and resources across entire organizations. While the MDR deadline for implementation begins in May 2021, orthopedic manufacturers will be consumed by the new regulation for years to come. Hear from experts from Notified Bodies, as well as representatives of small and large orthopedic manufacturers, as they share their perspectives and lessons learned on the MDR journey. Individual expert presentations will be followed by panel and audience discussion.
Sharon Starowicz, Regulatory Consultant, Medical Device
Sharon Starowicz is a Regulatory Consultant who most recently served as the Director of Regulatory Policy Innovation, Global Orthopaedics, for Johnson & Johnson, where she was responsible for providing strategic regulatory guidance and expertise and, with a focus on the external environment, shaping the evolving global regulatory policies that impact the medical device industry. Ms. Starowicz has over 30 years of regulatory affairs experience, specializing in Class I, II and III orthopedic and spinal devices.
Matthias Fink, M.D., Manager Clinical Focus Team North America, TÜV SÜD
Dr. Fink is a board-certified surgeon and medical professional with over 17 years of experience in orthopedic, trauma and reconstructive surgery. He has expert knowledge in the field of orthopedic implants and cardiac devices.
Mark Schenk, Vice President of Advanced Solutions and Vice President of Regulatory, Tyber Medical
Mr. Schenk has more than 20 years of experience working in the medical device industry, specifically in quality and regulatory assurance roles. Mr. Schenk was responsible for setting up the entire quality system at Tyber Medical. He oversees regulatory submissions around the world, including MDR compliance and submissions for Tyber Medical.
Bassil Akra, Ph.D., CEO and Co-Owner, QUNIQUE
Dr. Akra spent the last decade as a subject matter expert at the biggest notified body in Europe and represented locally and globally the notified body association in various European discussions. He was the Vice President of strategic business development at the Global Medical Health Services of TÜV SÜD Product Service, and played an essential role during the implementation of the medical device regulation (MDR 2017/745) in Europe, helping draft several European guidance documents (e.g. MEDDEV, MDCG, etc.).
Kim Trautman, Medical Device, IVD and Combination Product Expert
Kimberly Trautman is an experienced Medical Devices and InVitro Diagnostics Expert with over 30 years of experience. She worked at the U.S. FDA for 24 years and continues to work with Regulatory Agencies around the globe. She is an expert in global medical device regulations, wrote and harmonized the current U.S. FDA Quality System Regulation and was on the international authoring group of ISO 13485 since inception. She conceived and developed the Medical Device Single Audit Program and its consortium of five Global Regulators. Ms. Trautman is a 20-year veteran of the Global Harmonization Tasks Force (GHTF) and foundational member of the International Medical Device Regulators Forum (IMDRF).
Kevin D. Madden, Team Training Lead & Technical Team Manager, BSI
Kevin Madden joined BSI in 2015 as Product Specialist - Orthopaedic & Dental, and escalated to his present position in 2019. He spent seven years at Stryker in various engineering roles. Mr. Madden holds diplomas from The Institute of Project Management Ireland and earned his Bachelor of Engineering (B.Eng.) Biomedical Engineering degree at the University of Limerick.