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LTR Weekly Digest #29 - 23rd March, 2024

Catch up on this week's articles - bonus podcasts about QMSR, risk management plan requirements, new approach to learning medical software and medical AI, and a quick tip about risk management audits.

Dear colleagues, hello! 👋

A special welcome to the 30 + new members who have joined our Let’s Talk Risk! community last week! Feel free to browse past articles in the archive section of the Let’s Talk Risk! website, and check out recordings of recent LTR conversations in the podcast section.


Here are links to articles published this week.


I was recently invited as a guest on the Factor podcast to discuss QMSR and risk management

1. With Shannon Hoste and Nathan Blazei


Announcements

LTR monthly webinar series: How to create a master harms list using standard codes

A final reminder to join me in this month’s webinar, where I will review standardized codes and terms, and provide a step by step example of creating a master harms list for a medical device using public data.

If you are a paid subscriber, you will receive an email with a link to register for this month’s webinar on March 26, 2024 at 11:00 AM EST. You don’t need to pay extra.

If not, you can still attend this webinar with a one time payment of only $25. Click the link below to make a payment and secure your spot. Once you complete the payment, you will receive the registration link by email.

Register now to attend (Only $25)


LTR weekly conversation on LinkedIn: The power of communication and collaboration for QA/RA professionals

Join me next Friday, March 29, 2024 at 11:00 AM EST, for another Let’s Talk Risk! conversation on LinkedIn. My guest this week is Victor Mencarelli, who will share how effective communication and collaboration can help QA/RA professionals achieve career success.

Register here


Weekly Knowledge Challenge

I hope you enjoyed the knowledge challenge question last week. Here is the correct answer:

The correct answer for the question, “Since the term harm implies physical injury, use of ‘no harm’ as a descriptor of severity level 1 harms is inconsistent with ISO 14971.” is False.

Here is this weeks’ knowledge challenge #26

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