Global Regulatory Roundtable: FDA and Notified Bodies Outlook


Tuesday, June 15 | 3:00 pm - 4:30 pm


Room 45


All Levels

Participant Type:

All Roles

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 officials and Notified Body experts from TÜV SÜD and BSI discuss regulatory framework updates and the current approach to harmonization of international regulatory requirements.

Learning Objectives

  • FDA’s Total Product Life Cycle (TPLC) organizational structure and how premarket and postmarket activities are managed in the new operational model

  • U.S. and EU regulators’ strategic priorities and areas of focus

  • Understand how innovation has impacted FDA’s approach to regulation

  • FDA’s outreach efforts and ways in which FDA engages with different stakeholders within the orthopedic ecosystem

  • How the International Medical Device Regulators Forum (IMDRF) is promoting the global harmonization of regulatory requirements

  • Medical Device Single Audit Program (MDSAP) status and future opportunities


Sharon Starowicz

Regulatory Consultant,

Medical Device


Matthias Fink, M.D.

Clinical Reviewer, Clinical Centre of Excellence,


Mark N. Melkerson

Deputy Director, OHT6-Orthopedic Devices, Office of Product Evaluation and Quality,


Kim Trautman

Executive Vice President, Medical Device International Services,

NSF International

Monisha Phillips, Ph.D.

Global Head, Orthopedic and Dental Devices,