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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Thank you for your support and I hope you enjoy reading these latest articles!
Here are the articles published this week
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Case study - when miscalculating risk leads to a warning letter
In a recent warning letter, the United States Food and Drug Administration (US FDA) reprimanded a manufacturer of an ambulatory cardiac monitoring system for not correctly following their own procedures, which led to a miscalculation in the risk level and negatively impacted an important decision:
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Career tip - learn to effectively communicate regulatory risk in business terms
Note: this article highlights key insights gained from a conversation with Steven Silverman as part of the Let’s Talk Risk! with Dr. Naveen Agarwal series on LinkedIn. Listen to the full recording of the discussion below. If you enjoyed this Let’s Talk Risk!
Quick Tip: 4 keys for success with FMEAs
There is a reason why IEC 60812, the international standard for Failure Modes and Effects Analysis (FMEA) starts with planning as the first step. Planning helps you define the objective and scope of your analysis, identify boundaries and levels for analysis, define required resources and decision making criteria. It is not uncommon to see FMEAs being co…