Key MedTech Subjects Highlighted at 2021 International Standards Conference


September 28, 2021

Categories: AAMI News, HTM Professionals, Medical Device Manufacturers, Sterilization Professionals

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For more than 30 years, the International Conference on Medical Device Standards and Regulation (International Standards Conference, ISC) has been the key forum for insights on standards and regulatory developments across the globe, while providing a fresh look at critical, disruptive technologies.

Hosted by the Association for the Advancement of Medical Instrumentation (AAMI) the AAMI/FDA/BSI 2021 ISC is being held remotely to ensure attendees and presenters—among them industry representatives, regulators, clinicians, engineers, and academics—are not limited by travel restrictions.

The Names You Know

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The virtual conference will kick off on October 18 with a keynote presentation from Jeffery E. Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health (CDRH).

Shuren will describe how the FDA is working to ensure the safety and effectiveness of medical devices across a product’s entire lifecycle—a daunting challenge in an era of rapid change and technological advancement.

The FDA’s Total Product Life Cycle (TPLC) approach “promotes and enhances the safety and effectiveness of medical devices by strengthening CDRH’s focus on the device life cycle, from device design and development to real-world use,” Shuren explained. “It also ensures transparency, efficiency, and agility of CDRH’s regulatory oversight by making communication and information sharing across CDRH easier. This is critical for not just ensuring that authorized devices remain safe and effective once on the market, but to also inform future device modifications and new technologies that are subject to premarket review.”

The conference will conclude on October 20 with "Consumer Facing Health AI: Ensuring the Safety and Effectiveness of Personal Health Devices and Technologies," presented by Jesse M. Ehrenfeld, MD, MPH, a member (and recent chair) of the American Medical Association Board of Trustees and senior associate dean at the Medical College of Wisconsin.

Ehrenfeld is the co-chair of AAMI’s new standards committee dedicated to creating guidance for the development and use of artificial intelligence and machine learning in medical devices and systems.

“Regulators, innovators, consumers and physicians alike need to understand the looming implications for consumer facing Health AI," he explained. “As these technologies burst onto the marketplace, ensuring the safety and effectiveness of personal health devices and technologies will be critical to maintaining the public trust. I am excited to share my perspectives as a physician and informatician.”

The Subjects You Care About

Nestled between these pertinent keynotes will be networking opportunities and three days of sessions to catch using the remote conference’s browser and app-based platform.

“As always, the ISC will be a dynamic review of recent changes and a look to what’s ahead in medtech standards and regulation, but this year each day will have a different focus,” added Joe Lewelling, senior advisor, content and strategy at AAMI.

  • Day one will feature sessions covering U.S. developments, with a special focus on the impact and lessons learned from COVID-19 with updates from regulators and standards developers.
  • Day two will have a focus on international change. Some examples of the day’s session include a report on the implementation of the EU Medical Device Directives and the UK Medicines and Healthcare products Regulatory Agency’s developing post-Brexit regulatory framework, an update on the efforts of the International Medical Device Regulators Forum to promote global regulatory harmonization, and a discussion concerning developments in Indian medical device regulations and standards adoption.
  • Day three will concentrate on critical technologies. Sessions will highlight regulatory and standards news on cybersecurity issues, combination products, the use of cloud computing with medical devices, unique device identification (UDI) systems, and artificial intelligence.

“I look forward to joining this year’s International Conference on Medical Device Standards and Regulation to hear from a diverse group of stakeholders on a range of pressing topics related to medical devices, COVID-19 lessons learned, and the future advancements of our industry,” added Shuren.

More information, including a detailed sessions list, can be found at the registration page. AAMI members can attend the virtual conference at a discounted rate.

Members of the media seeking press passes should contact Media Relations Manager Brian Stallard (
bstallard@aami.org).