Dear colleagues, hello! 👋
A special welcome to the 40 new members who 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.
Bonus free podcast:
LTR 41: MDSAP, getting ready for QMSR, and career tips with Rick Rios
Feature article (premium):
Other articles:
Announcements
LTR monthly webinar series: How to set up post-market surveillance for your medical device
A quick reminder to join me in this month’s webinar, where I will review ISO 14971 requirements for post-market surveillance and a simple operational model.
If you are a paid subscriber, you will receive an email with a link to register for this month’s webinar on May 22, 2024 at 11:00 AM EST. You don’t need to pay extra.
If not, you can upgrade your subscription, or pay a one time fee of only $25 to attend this webinar. 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.
LTR weekly conversation on LinkedIn: Challenges and best practices for usability engineering in medical device development
Join me next Friday, May 24, 2024 at 11:00 AM EST, for another Let’s Talk Risk! conversation on LinkedIn. My guest is Korey Johnson, who will share best practices for HFE in medical device design and development.
Weekly Knowledge Challenge
I hope you enjoyed the knowledge challenge question last week. Here is the correct answer:
The correct answer to the question, “Which of the following is NOT an element of the intended use statement of a medical device” is Instructions for use.
Here is this weeks’ knowledge challenge #34
1-Question Feedback Survey
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