HeyJaredLet's Talk Risk!
Where MedTech professionals gain clarity and confidence to navigate complex risk, quality, and leadership challenges.
Part of Let's Talk Risk! with Dr. Naveen Agarwal. Follow the publication for all its platforms.
- Indexed issues, last 90 days
- 19
- Latest publication
- Sep 29, 2026
- Audience
- Checking…
- Earliest in this view
- Aug 17, 2026
Latest issues
QMSR QuickTake #44: A Device Can Be “Finished” Before It Is Final (opens the original)
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In responding to Comment #33 in the preamble of the QMSR1, FDA addresses an important boundary question: when is something a component, and when has it become a finished device?That distinction matters because QMSR generally applies directly to manufacturers of finished devices, while manufacturers that only produce components or parts are generally not directly subject to QMSR.<a class="image-link image2 is-viewable-img" href="https://substackcdn.com/image/fetch/$s_!Hl8y!,f_auto,q_auto:good,fl_
TAI #44: The Supplier Risk Traceability Gap (opens the original)
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<img alt="" class="sizing-normal" height="630" src="https://substackcdn.com/image/fetch/$s_!1MNj!,w_1456,c_limit,f_auto,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2Fb91a314c-cf96-4fb1-98e8-edc2ffdf28ee_1200x630.png"
Deep Dive: When the Risk Baseline and the QMS Both Break Down (opens the original)
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The baseline is completely broken and the iteration process is blind.FDA’s August 21, 2026 warning letter to Pensar Medical LLC illustrates a failure that goes well beyond incomplete documentation.The underlying risk-management foundation was weak. Risk-control verification remained incomplete for critical areas, and FDA reportedly found no design, process, or use-related FMEAs for the WoundPro product line.At the same time, key QMS processes were also failing.Key highlights covered in the audio
QMSR QuickTake #43: QMS Risk Is Broader Than ISO 14971 (opens the original)
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In responding to Comment #32 in the preamble of the QMSR1, FDA pointed manufacturers back to ISO 13485 Clause 0.2 within the standard. The term risk relates to device safety, device performance, and meeting applicable regulatory requirements.<a class="image-link image2 is-viewable-img" href="https://substackcdn.com/image/fetch/$s_!t9bO!,f_auto,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2Fe682122e-d973-416f-ac64-2bbcd41d0097_1080x1350.pn
TAI #43: How Traceable Are Safety-Related Characteristics in Your Risk File? (opens the original)
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<img alt="" class="sizing-normal" height="630" src="https://substackcdn.com/image/fetch/$s_!S3Pr!,w_1456,c_limit,f_auto,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2F17a705dc-1c54-474a-b737-9289ea8034db_1200x630.png"
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