Yesterday, AAMI made a draft version of ISO/TR 24971 available as a pre-order, and on we will be explaining the new risk management guidance on February 10.
Yesterday, AAMI released a pre-order version of the ISO/TR 24971 guidance for the application of risk management of medical devices. The final version will be made available on February 2, and we are offering a live training webinar on February 10. The webinar will begin at 1:00pm EST (10am PT), and the webinar will be a Zoom meeting. All attendees will be able to ask questions, you will receive the native slide deck, and you will receive a recording of the webinar.
Register for the live webinar on ISO/TR 24971:2020 for $129
This is a one-hour webinar providing a training overview on the new ISO/TR 24971:2020 risk management guidance for medical devices that was released as a pre-order through AAMI on January 19, 2020.
Includes the following: 1) ISO 14971 risk management training webinar, 2) Updated Risk Management Procedure (SYS-010), 3) ISO/TR 24971:2020 risk management training webinar, 4) Updated Risk Management Training Exam, 5) a signed training certificate, and 6) a corrected exam.
Updated ISO 14971:2019 risk management standard
On December 17, we posted a new blog about the ISO 14971:2019 standard that was released on December 16, 2019. We already updated our risk management training to the 2019 version based upon the 2018 draft that was released. However, we made additional updates to the procedure to include references to this 2019 version and Regulation (EU) 2017/745. We will be making additional updates to the procedure based upon this new ISO/TR 24971:2020 guidance on risk management for medical devices.
3-Hour Risk Management Training Workshop – April 14 in San Diego
We are also teaching a 3-hour risk management workshop in San Diego on April 14. The workshop is being hosted by Joe Hage at the 10x Medical Device Conference. If you are interested in attending, please sign-up soon to receive a discounted price.
The workshop will have 3 parts. Rob Packard will explain what changed in Part 1. Mary Vater will explain the impact of these changes on your software development documentation. During Part 3, we will open the workshop to an extra long Q&A session to answer your specific questions.
You might be curious why we are devoting one-third of the workshop to software development. EN ISO 14971:2012 only used the word “software” once in the body of the standard, and 13 times in the annexes; while ISO 14971:2019 uses the word “software” 8 times, and ISO/TR 24971:2020 uses the word “software” 46 times. There is more emphasis on the application of risk management, because integrating devices with software applications is the single biggest trend in our industry. We also know that documenting software risk management is your weakness.