Regulatory bodies globally have adjusted priorities to respond to the COVID-19 pandemic. Understanding the current landscape and future direction of the global regulatory environment is critical to ensure that requirements are met for market introduction of new products and their continued postmarket compliance. This regulatory roundtable highlights hot topics and strategic priorities imperative to orthopedic manufacturers doing business. Hear FDA and Notified Body officials discuss regulatory framework updates and the current approach to harmonization of international regulatory requirements.
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.
Raquel A. Peat, Ph.D., Director, OHT6: Office of Orthopedic Devices, Food and Drug Administration
Captain (CAPT/O-6) Raquel Peat, Ph.D., MPH, MS is a microbiologist and an Officer in the United States Public Health Service. Captain Peat has over 25 years of experience as a technical and regulatory expert, and as a manager and leader, in a variety of areas including drugs, medical devices and tobacco products. She is stationed at FDA as the Director for the Office of Health Technology 6: Office of Orthopedic Devices in the Office of Product Evaluation and Quality, Center for Devices and Radiological Health, which is responsible for regulating orthopedic devices for premarket and postmarket activities in a Total Product Life Cycle organization.
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.
Dr. Fink has worked as a Clinical Reviewer for the Clinical Centre of Excellence for TÜV SÜD Product Service since 2016 and as the Team Leader for the ortho and trauma team since 2018.
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 a 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.