AAMI News February 2019

AAMI Standards Conference to Help Attendees Navigate Changing Global Regulatory Landscape

Understanding evolving standards and regulations is crucial for medical device manufacturers to enjoy continued compliance and global market access. To help clarify recent and upcoming changes to U.S. and international standards and regulations for medical devices and other health technologies, AAMI is hosting a two-day conference this spring with the Food and Drug Administration (FDA) and BSI, the national standards body for the United Kingdom.

The International Conference on Medical Device Standards and Regulations, which will be held April 24–25 at the Reston Hyatt Regency in Virginia, will bring together regulators and standards leaders from around the world to report on some of the biggest developments in this arena.

“The healthcare technology industry is facing a number of significant regulatory shifts in many parts of the world, and there are a number of areas where we anticipate international standards or their implementation to change,” said Joe Lewelling, vice president of emerging technologies and health IT at AAMI. “This conference will provide updates and analysis of new FDA initiatives and the European Medical Device Regulation, as well as review changes to key international standards.”

Planned sessions will cover:

  • The FDA’s standards recognition program, digital health initiatives, and the new 510(k) pathway.
  • Implementation of the European Medical Device Regulation and the implications of Brexit.
  • The Medical Device Single Audit Program.
  • International Medical Device Regulators Forum initiatives.
  • Expected changes to ISO 14971, Medical devices—Application of risk management to medical devices.
  • The future of quality management systems, including the proposed switch from 21 CFR 820 to ANSI/AAMI/ISO 13485 and the possible alignment of 13485 and ISO 9001.
  • New cybersecurity laws and standards.
  • The convergence of medical devices and consumer products.
  • Standards development for health software, health IT, artificial intelligence, and machine-learning algorithms.

For more information and to register, visit www.aami.org/ISC.