April 4–5, 2017

Herndon, VA


AAMI, in partnership with the British Standards Institution (BSI) and the Food and Drug Administration (FDA), presents the Symposium on the Evolving Standards and Regulatory Structure for Medical Devices.

Join colleagues from across the healthcare technology industry to hear about the latest developments in global regulations and standards. Discussions will include:

  • Implications of the 21st Century Cures Act
  • Preview of Medical Device User Fee Amendments 2017 (MDUFA IV)
  • Update on the European Medical Device Regulation (MDR)
  • Recent and coming changes to key international standards (ISO 13485, ISO 14971, etc.)
  • The shift in regulations and standards to a postmarket focus

Who Should Attend

  • Professionals from medical technology and IVD companies who have responsibility for standards and regulatory compliance
  • Suppliers to medical device and IVD companies
  • Industry consultants

Speakers

AAMI, BSI, and the FDA present subject knowledge experts who will provide the latest information to help attendees reach compliance in this changing regulatory landscape.

  • Stefan Burde, IVD Product Expert, BSI
  • Scott Colburn, MS, BSN, RN, Director, CDRH Standards Program, FDA
  • Anita Finnegan, Researcher, Dundalk Institute of Technology
  • Eamonn Hoxey, PhD, BPharm, FRPharmS
  • Patricia Murphy, Global MDSAP Manager, BSI
  • Bakul Patel, MSEE,  MBA, Policy Advisor, CDRH/FDA
  • Ronald Rakos, PHD, Global Head of Vascular, BSI
  • Terrie Reed, MSIE, FDA Senior Advisor for UDI Adoption
  • Ibim Tariah, Technical Director, BSI Americas

Resources


Seats are limited
, so please register now.