Let's Talk Risk!
Naveen Agarwal, Ph.D., Pujitha GourabathiniWhere MedTech professionals gain clarity and confidence to navigate complex risk, quality, and leadership challenges.
| Platform |  | Pricing | Freemium | Publishes | Daily |
|---|---|---|---|---|---|
| Issues | 512 | Founded | 3 years ago | Last Issue | 8 days ago |
| Active | |||||
Read this Newsletter
naveenagarwalphd.substack.comLatest Issues
QMSR QuickTake #25: QMSR Readiness Is Not a Template Exercise
In responding to Comment #23 in the preamble of the QMSR1, FDA declines to provide prescriptive advice on how to evaluate or update an existing QMS for QMSR compliance.
Because each organization’s QMS is unique to its operations, there is...
TAI #25: When "No Findings" Masks a Critical Blind Spot
Dear colleagues:
In MedTech, we are often quick to interpret a clean audit as good news. No findings. No major observations. No obvious concerns. On the surface, that sounds like assurance.
Sometimes it is. But not always.
In complex sys...
LTR 154: From Procedures to Judgment - Leading Through QMSR Inspections
Summary
“FDA isn’t just inspecting procedures anymore. They are looking at how risk-based decisions are actually made.”
In this episode of the Let’s Talk Risk Podcast, host Naveen Agarwal speaks with Michelle Lott about what early FDA...
Lifecycle Risk Integration, Part 2: Reading a Warning Letter Through FDA’s New Inspection Lens
This essay is part of our 90-day QMSR Readiness Action Plan, which outlines five critical areas the help QA/RA leaders to prepare for this news regulatory environment. Here we focus on how FDA is likely to interpret lifecycle risk integrati...
QMSR QuickTake #24: Why Definitions Matter More Than You Think
In responding to Comment #22 in the preamble of the QMSR1, FDA notes that certain definitions in ISO 13485 cannot be adopted because they conflict with or differ from definitions established in the FD&C Act.
At first glance, this appears t...
Audience Metrics
Subscribers, engagement, traffic and sponsorship for Let's Talk Risk!.
| Subscribers | Engagement | 71 | Monthly Web Visits | ||
|---|---|---|---|---|---|
| Accepts Sponsors | Estimated Cost per Ad | ||||
Chart Rankings
How this newsletter ranks in the official Substack charts.
| #184 |
Authors
The writers behind this newsletter.
MedTech risk management advisor, educator, and creator of Let’s Talk Risk! Sharing ideas on risk, quality, leadership, and decision-making under uncertainty.
A quality nerd in the medical world! I write about how quality in healthcare tech keeps patients safe and medical products compliant behind the scenes.
Social
Frequently Asked Questions
How can I access the email archive for Let's Talk Risk!?
You can find recent issues that have been published by Let's Talk Risk! on Reletter by scrolling up to where it says Latest Issues. Tap on the link for any of the most recent emails or hit More Issues to see older ones.
How many subscribers does Let's Talk Risk! have?
To see how many people subscribe to Let's Talk Risk!, simply upgrade your Reletter account. We provide readership numbers and lots of other stats for this newsletter so you can decide if it's worth reaching out to.
How can I advertise in Let's Talk Risk!?
Newsletter advertising can be extremely effective when it's done right. Before you pitch Let's Talk Risk! as a potential sponsor or partner, make sure that you've done your research and checked its newsletter stats with Reletter.
Then, personalize one of our winning pitching templates and send it to the right person using the contact info provided.
How much does it cost to sponsor a publication like Let's Talk Risk!?
Newsletter ad rates (or CPM) vary depending on many factors, including industry, number of subscribers, open rate, ad placement and more.
To find out how much an ad will cost, contact Let's Talk Risk! using the contact information provided and ask for a copy of their media kit.
How can I find newsletters related to Let's Talk Risk!?
Scroll up to where it says Related Newsletters to see other publications like Let's Talk Risk!. You can also search our email newsletter directory to discover other newsletters that cover the topics you're interested in.
How do I contact Let's Talk Risk!?
Reletter provides this newsletter's website URL above, where you will often find their contact information. We also provide links to associated social media accounts and pitching templates so you can reach out fast.