LTR Weekly Digest #4 - 16th September, 2023
Catch up on this week's articles: 7 essential elements of risk management plan, building the empathy muscle for success, and getting comfortable with a probabilistic approach to risk management.
Dear colleagues, hello! 👋
We all know that good planning is critical to success in any project, and risk management is no different. That is why a risk management plan is an essential requirement of ISO 14971. Learn more about the 7-essential elements of a risk management plan in this recorded webinar.
Want to know a secret? If you are a risk practitioner, you can significantly boost your chances of success by working out your empathy muscle! Listen to the recording of a recent Let’s Talk Risk! conversation here to learn more.
Finally, a quick tip to get comfortable with probability when managing risk, because relying on your gut is likely to mislead you sometime!
Live ISO 14971 training starts in early Oct 2023
Sign up today to save your spot in the next session of my Live ISO 14971 training starting early Oct 2023. Paid subscribers get 20% off list price.
Space is limited to only 15 attendees at one time. Pre-register here:
Attend this month’s webinar on Sep 26, 2023
A quick reminder to register for the September webinar where we will go deeper into 2 ways of estimating the probability of occurrence of harm (POH).
If you are a paid subscriber, you will receive an email with a link to register for this month’s webinar on Sep 26, 2023 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.
Ask a risk management question
Now you can ask a risk management question for quick answer and practical tips!
Weekly knowledge challenge
I hope you enjoyed the knowledge challenge question last week. Here is the correct answer:
The best estimate of P2 for the scenario where 20 of the 200 events of a medical device malfunction were confirmed to have resulted in a serious harm is 0.1.
Want to learn more about a simple method of estimating P1, P2 and the probability of harm using post-market data? Check out this case study from last week.
Check out this week’s knowledge challenge question by scrolling down to the end.
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Thank you for your support and I hope you enjoy reading these latest articles!
