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 Podcast 13-  Cybersecurity in Healthcare Technology [not-audio_url] [/not-audio_url]

Duration: 36:06
With hospital data breaches—and stiff fines—on the rise and a growing black market for patient information, cybersecurity is one of the more pressing issues in healthcare technology. How can healthcare facilities keep pa…
AAMI Podcast 11- The Big Deal about Big Data [not-audio_url] [/not-audio_url]

Duration: 40:18
More medical device collect and store patient information and other data than ever before. In turn, these devices are connected to network systems. How can healthcare facilities turn this growing pile of data into someth…
AAMI Podcast 10- Is PM a Thing of the Past? [not-audio_url] [/not-audio_url]

Duration: 29:44
In this provocative conversation, Stephen Grimes, chief technology officer of ABM Healthcare Support Services, says healthcare technology management (HTM) professionals must rethink the entire concept of preventive maint…
AAMI Podcast Episode 9- Risk Management [not-audio_url] [/not-audio_url]

Duration: 35:32
Increasingly seen as a crucial discipline in effective healthcare, risk management can mean different things to different people, but one common theme is that it can help create a “safe environment” for patients. Jacque…
AAMI Podcast Episode 8- Imaging Insights [not-audio_url] [/not-audio_url]

Duration: 43:24
Enjoy an engrossing and personal conversation with a veteran imaging service engineer who talks about the challenges he faces, his relationship with third-party vendors, his advice to manufacturers, and the very best par…
AAMI Podcast Episode 6-Systems Thinking in Healthcare [not-audio_url] [/not-audio_url]

Duration: 42:25
The notion of “systems thinking” is one that has been adopted in a number of industries, such as aviation and defense. It’s a concept that’s getting more attention in healthcare as its delivery gets more complicated, tec…
AAMI Podcast Episode 4- Ebola and Sterilization Challenges. [not-audio_url] [/not-audio_url]

Duration: 44:45
The Ebola outbreak has focused new attention on the crucial role of sterilization and disinfection in healthcare. Cynthia Spry, an independent clinical consultant and co-chair of AAMI’s Steam Sterilization Hospital Pract…