AAMI Podcast 25: Changing Requirements for Quality Management Systems

AAMI Podcast 25: Changing Requirements for Quality Management Systems

Author: Association for the Advancement of Medical Instrumentation February 26, 2018 Duration: 20:26

Recognized by many jurisdictions around the world, the standard ANSI/AAMI/ISO 13485:2016, Medical Devices; Quality management systems; Requirements for regulatory purposes, provides structured guidance to help organizations meet regulatory requirements. In this episode, international quality and regulatory compliance consultant Eamonn Hoxey describes the major differences between the 2003 and 2016 editions of 13485. As we near the end of a three-year transition period for medical device developers and manufacturers to comply with requirements set forth in the 2016 edition of the standard, Hoxey discusses how the new updated version clarifies expectations for manufacturers, providing a much more global, comprehensive, and harmonized approach to meeting requirements.

Learn more at AAMI.org


Tune into The Association for the Advancement of Medical Instrumentation Podcast-AAMI for candid conversations that go straight to the heart of healthcare technology. Hosts Terry Baker and Kelley Hill guide these discussions, joined each episode by leading subject matter experts who bring real-world perspective. You’ll hear detailed explorations of the field's most urgent challenges, from device interoperability and cybersecurity risks to the practical realities of sterilization and standards implementation. This isn't just theoretical; the dialogue focuses on the multidisciplinary, collaborative approaches that teams are actually using to find solutions and improve patient care. Produced in partnership with the studios of Healthcare Tech Talk, the podcast serves as an essential audio resource for anyone invested in the lifecycle of medical technology-whether you're a clinical engineer, a sterile processing professional, a risk manager, or simply fascinated by how innovation meets clinical practice. Each episode breaks down complex topics into relatable insights, fostering a deeper understanding of the instruments and systems that modern medicine relies upon every single day.
Author: Language: English Episodes: 34

The Association for the Advancement of  Medical Instrumentation Podcast - AAMI
Podcast Episodes
AAMI Episode 3- Building Stronger HTM Departments [not-audio_url] [/not-audio_url]

Duration: 54:05
Three veteran clinical engineers talk about how healthcare technology management (HTM) departments can move forward and make themselves even more valuable to their organizations. Frank Painter, a professor at the Univers…
AAMI Episode 2- Ventilator Technology [not-audio_url] [/not-audio_url]

Duration: 49:15
Hours, even days, could be spent on the subject of ventilator technology and all of its challenges, innovations, and nuances. This episode we sit down with three industry experts to discuss the complications associated w…
AAMI Episode 1 - An Interview with AAMI President Mary Logan [not-audio_url] [/not-audio_url]

Duration: 24:11
We are joined by Mary Logan, Pesident and CEO of the Association for the Advancement of Medcial Intrumentation (AAMI), for the launch of the new AAMI podcast series. Mary talks with us about the decision to add a podcast…