LTR Weekly Digest #8 - 14th October, 2023
Catch up on this week's articles: case study about miscalculating risk, career tip for regulatory professionals and best practices for success with FMEAs
Dear colleagues, hello! 👋
Imagine your medical safety team is conducting a health hazard evaluation (HHE) on a recently discovered device issue with a potential impact on patient safety. Now imagine that a simple miscalculation in the probability value leads them to incorrectly judge the risk level to be low, and not recommend any follow up actions.
Indeed, a simple miscalculation can lead to a significant error in judgment! In a case study article this week, I have analyzed a recent FDA warning letter to help you understand this situation at a deeper level. If you are not yet a paid subscriber, you can still read the full article with a 7-day free trial.
Chances are that you are using an FMEA for risk analysis. Chances are, you find the process of completing an FMEA quite challenging, with a lot of guess work, arguments and frustration! Here are some best practices to achieve success with FMEAs and take some of the pain out!
Finally a career tip for Quality/Regulatory professionals - developing skills in analyzing regulatory risks, and effectively communicating them in business terms, can be a significant competitive advantage for advancing your career. Listen to a recording of a recent Let’s Talk Risk! conversation here.
Attend this month’s webinar on Oct 24, 2023
A quick reminder to register for the October webinar where I will share a practical approach to analyze benefit-risk for a medical device.
If you are a paid subscriber, you will receive an email with a link to register for this month’s webinar on October 24, 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.
Weekly knowledge challenge
I hope you enjoyed the knowledge challenge question last week. Here is the correct answer:
The statement “there is no need to monitor risks during the post-market phase of a single-use, disposable medical device such as a contact lens, because it is used only once and discarded” is FALSE.
Check out this week’s knowledge challenge question by scrolling down to the end.
Pre-registration now open in the next phase of LIVE ISO 14971 training
We kicked off the current session of LIVE ISO 14971 training this week! This is a specially designed training to help you master the requirements of ISO 14971, and get some hands-on experience by building a risk management file from scratch. Each week, we meet for a 2h live session for a total of 5 sessions for the whole training. This way, you don’t have to take too much time off from work and you can absorb the training material in bite-size pieces. Learn about this training here.
If you are interested, you can pre-register here for the session starting in November, 2023. Cost of the training is $899 USD. Paid subscribers on the annual plan get a 20% discount!.
Space is limited to only 15 attendees at one time. Pre-register here:
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