# benefit-risk — RSS Amplifier Recent posts from the 3 feeds in the RSS Amplifier directory that cover benefit-risk. Page: Feed: --- ## [QMSR QuickTake #38: "Documented" Does Not Mean Paper-Only](https://naveenagarwalphd.substack.com/p/qmsr-quicktake-38-documented-does-mean-paper-only) _2026-08-18 · Let's Talk Risk!_ Under QMSR, a documented QMS processes must be more than written; it must be established, implemented, and maintained. ## [TAI #38: Are We Asking Too Much of FMEA?](https://naveenagarwalphd.substack.com/p/tai-38-are-we-asking-too-much-of-fmea) _2026-08-17 · Let's Talk Risk!_ FMEA is valuable, but complex risks of harm may require pathway-based analysis to understand how events combine and controls interact. ## [LTR 163: FDA’s New Risk Lens Under QMSR](https://naveenagarwalphd.substack.com/p/ltr-163-fdas-new-risk-lens-under-qmsr) _2026-08-14 · Let's Talk Risk!_ Allyson Mullen examines how QMSR is changing FDA’s approach to risk, inspections, quality agreements, and accountability across the quality system. [Listen](https://api.substack.com/feed/podcast/210908159/6ded0fa2d9b3fb3a6c431ece56339119.mp3) ## [QMSR QuickTake #37: FDA Removed the Definitions, Not the Expectations](https://naveenagarwalphd.substack.com/p/qmsr-quicktake-37-fda-removed-the-definitions-not-the-expectations) _2026-08-11 · Let's Talk Risk!_ QMSR removes explicit definitions for process and design validation, but not the underlying validation obligations. ## [TAI #37: Do We Really Understand Risk Control Effectiveness?](https://naveenagarwalphd.substack.com/p/tai-37-do-we-really-understand-risk-control-effectiveness) _2026-08-10 · Let's Talk Risk!_ If we cannot explain how controls change the pathway to harm, we cannot confidently define, measure, or monitor their effectiveness. ## [How to be a lactivist.](https://maternalstressproject.substack.com/p/how-to-be-a-lactivist-38b) _2026-08-07 · Molly Dickens, PhD · The Maternal Stress Project_ It’s National Breastfeeding Month and I have a lot of thoughts… ## [AUDIO -- How to be a lactivist](https://maternalstressproject.substack.com/p/how-to-be-a-lactivist) _2026-08-07 · Molly Dickens, PhD · The Maternal Stress Project_ It’s National Breastfeeding Month and I have some thoughts… [Listen](https://api.substack.com/feed/podcast/210214264/7bb6c35e7c02e5ef83d3a4be301aa368.mp3) ## [Deep Dive: First FDA Warning Letter Under QMSR](https://naveenagarwalphd.substack.com/p/deep-dive-first-fda-warning-letter-under-qmsr) _2026-08-07 · Naveen Agarwal, Ph.D. · Let's Talk Risk!_ What the Linemaster warning letter reveals about FDA’s emerging inspection and enforcement approach. [Listen](https://api.substack.com/feed/podcast/209510184/4dd49aeee193876bf7dc9919d07fdc9f.mp3) ## [QMSR QuickTake #36: Why Batch and Lot Still Matter](https://naveenagarwalphd.substack.com/p/qmsr-quicktake-36-why-batch-and-lot-still-matter) _2026-08-04 · Let's Talk Risk!_ FDA retained the batch/lot definition because QMSR needs clarity around the affected product population when manufacturers evaluate nonconformity, correction, CAPA, traceability, and risk. ## [TAI #36: When The Average Hides Uneven Benefit-Risk](https://naveenagarwalphd.substack.com/p/tai-36-when-the-average-hides-uneven-benefit-risk) _2026-08-03 · Let's Talk Risk!_ A device may appear safe and effective overall while vulnerable patient subgroups experience a meaningfully less favorable benefit-risk balance. ## [Refer a Friend, Earn Rewards (Sponsored)](https://crawlproof.com/a/i83oTkTm5qvD) _2026-08-03 · **Sponsored**_ Earn rewards when a friend signs up for the Graphite Business Card ## [LTR 162: Using HHE for Risk-Based Decisions](https://naveenagarwalphd.substack.com/p/ltr-162-using-hhe-for-risk-based-decisions) _2026-07-31 · Let's Talk Risk!_ Kerry Flecknoe explains how ISO 14971 can turn Health Hazard Evaluations into consistent, defensible postmarket risk decisions. [Listen](https://api.substack.com/feed/podcast/208987776/b899e3f5cc327b856ac973dfc0d15f95.mp3) ## [QMSR QuickTake #35: CAPA Effectiveness Is Not a Closure Checkbox](https://naveenagarwalphd.substack.com/p/qmsr-quicktake-35-capa-effectiveness-not-a-clousure-checkbox) _2026-07-28 · Let's Talk Risk!_ CAPA effectiveness is not proven by completion alone; it requires predefined criteria and evidence scaled to the underlying risk. ## [What if navigating healthcare (as a woman) didn't have to be so stressful?](https://maternalstressproject.substack.com/p/what-if-navigating-healthcare-as) _2026-07-21 · Molly Dickens, PhD · The Maternal Stress Project_ Last week's conversation with Priya Bathija from The Women's Health Playbook. [Listen](https://api.substack.com/feed/podcast/206132340/764bd798018e793f13000b13b0c820ae.mp3) ## [AUDIO -- What if navigating healthcare (as a woman) didn't have to be so stressful?](https://maternalstressproject.substack.com/p/audio-what-if-navigating-healthcare) _2026-07-21 · Molly Dickens, PhD · The Maternal Stress Project_ Last week's conversation with Priya Bathija from The Women's Health Playbook. [Listen](https://api.substack.com/feed/podcast/207581951/896edfb1f7ebbff51f07786316167247.mp3) ## [The placebo effect is real](https://maternalstressproject.substack.com/p/the-placebo-effect-is-real) _2026-07-07 · Molly Dickens, PhD · The Maternal Stress Project_ Benefits and risks of a cure that’s all in your head ## [AUDIO -- The placebo effect is real](https://maternalstressproject.substack.com/p/audio-the-placebo-effect-is-real) _2026-07-07 · Molly Dickens, PhD · The Maternal Stress Project_ Benefits and risks of a cure that's all in your head [Listen](https://api.substack.com/feed/podcast/205664200/2e7f4e38e0a7c94514ab1168d875e74b.mp3) ## [Why Does the U.S. Fertility Rate Include 14-Year-Olds?](https://maternalstressproject.substack.com/p/why-does-the-us-fertility-rate-include) _2026-06-18 · Molly Dickens, PhD · The Maternal Stress Project_ Can we just move the fuck away from this already?! ## [AUDIO -- Why Does the U.S. Fertility Rate Include 14-Year-Olds?](https://maternalstressproject.substack.com/p/audio-why-does-the-us-fertility-rate) _2026-06-18 · Molly Dickens, PhD · The Maternal Stress Project_ Can we just move the fuck away from this already?! [Listen](https://api.substack.com/feed/podcast/202503869/03bfa5ede10267f8f972bcb957c013e5.mp3) ## [“Great parents are made, not born”](https://maternalstressproject.substack.com/p/great-parents-are-made-not-born) _2026-06-07 · Molly Dickens, PhD · The Maternal Stress Project_ VIDEO -- Talking all things \*Dad Brain\* with Dr. Darby Saxbe [Listen](https://api.substack.com/feed/podcast/200332051/e304d2612b8147a2f88bb423d4ddfd48.mp3) ## [AUDIO -- “Great parents are made, not born”](https://maternalstressproject.substack.com/p/audio-great-parents-are-made-not) _2026-06-07 · Molly Dickens, PhD · The Maternal Stress Project_ Talking all things \*Dad Brain\* with Dr. Darby Saxbe [Listen](https://api.substack.com/feed/podcast/200786719/d65cf5ebfb5159b8ad2d0d8eb01a8a83.mp3) ## [Brisk AI News Briefings (Sponsored)](https://crawlproof.com/a/hZ3hSuSqpX7E) _2026-06-07 · **Sponsored**_ Read AI summaries and listen to audio briefings for top stories. ## [More Innovation Through Different Computation: Quantum Computing and the New Substrate of Science](https://travislscholten.substack.com/p/more-innovation-through-different) _2026-03-28 · Travis L Scholten · The Quantum Stack_ Because tomorrow's challenges can't be solved with yesterday's computers ## [The Future of Quantum Computing (No Crystal Balls Necessary)](https://travislscholten.substack.com/p/the-future-of-quantum-computing-no) _2026-02-02 · Travis L Scholten · The Quantum Stack_ What Industry Roadmaps Tell Us About the Coming Years ## [Architecting a New Operating System for American Science](https://travislscholten.substack.com/p/architecting-a-new-operating-system) _2025-12-30 · Travis L Scholten · The Quantum Stack_ A personal perspective on modernizing the engine of innovation ## [What National Security Leaders Need to Know About Quantum Computing](https://travislscholten.substack.com/p/what-national-security-leaders-need) _2025-11-18 · Travis L Scholten · The Quantum Stack_ Six Strategic Principles for Turning Quantum Potential into Mission Advantage ## [Re-Assessing the Benefits and Risks of Quantum Computers](https://travislscholten.substack.com/p/re-assessing-the-benefits-and-risks) _2025-09-18 · Travis L Scholten · The Quantum Stack_ Timelines are accelerating. ## [What Happens When Quantum Leaves the Lab?](https://travislscholten.substack.com/p/what-happens-when-quantum-leaves) _2025-08-07 · Travis L Scholten · The Quantum Stack_ How quantum computing is reshaping careers, communities, and our economy ## [Unpacking Quantum Algorithms, The Industry, & AI’s Role](https://travislscholten.substack.com/p/unpacking-quantum-algorithms-the) _2025-07-26 · Travis L Scholten · The Quantum Stack_ Insights from Recent Talks ## [Happy World Quantum Day!](https://travislscholten.substack.com/p/happy-world-quantum-day) _2025-04-14 · Travis L Scholten · The Quantum Stack_ A Look at Progress, Policy, and Promising Places on This Special Day ## [Five Thoughts for 2025](https://travislscholten.substack.com/p/five-thoughts-for-2025) _2024-12-20 · Travis L Scholten · The Quantum Stack_ The UN’s International Year of Quantum Science and Technology is soon upon us. Buckle in. ## [Open directory of blogs for agents (Sponsored)](https://crawlproof.com/a/YRcMaYlm9LjS) _2024-12-20 · **Sponsored**_ Submit URLs or OPML; receive feed pages with summaries, plus JSON/OPML/plain text ## [Act to Action: US Quantum Computing Policy Past, Present, and Future](https://travislscholten.substack.com/p/act-to-action-us-quantum-computing) _2024-11-22 · Travis L Scholten · The Quantum Stack_ From one POTUS to another, quantum policy marches on. Plus, I did a podcast!