Medical Device Courses | aca | Mentions https://medicaldevicecourses.com/members/aca/activity/mentions/ Activity feed mentioning aca. Sun, 15 Nov 2026 13:06:06 -0500 https://buddypress.org/?v= en-US 30 hourly 2 815e25f8064f449fd69a2b3a567f6321 31470977 replied to the topic "Why Clinical Trials Are Part of Device Development" - https://medicaldevicecourses.com/activity/p/60098/ Mon, 02 Nov 2026 04:55:34 -0500 @aca I don’t particularly think there should be an emphasis on patient diversity as clinical trials are meant to be done for the potential population who will utilize the medical device. If patient diversity is emphasized, companies could lose the…   Read more»

]]> 0f3602da1d997bb9abc900092d300834 ha572 replied to the topic "Can AI Replace Human Participants in Clinical Trials ?" - https://medicaldevicecourses.com/activity/p/59692/ Mon, 26 Oct 2026 00:36:39 -0400 @aca I agree that manufacturers should demonstrate that a medical device can be used safely by healthcare providers with appropriate training before receiving regulatory approval. Even if a device performs well in AI simulations, the results may be different depending…   Read more»

]]> 528588f2dd1e3a33c293dea6b41ebfa9 enzo.1216 replied to the topic "Quality Assurance vs. Quality Control" - https://medicaldevicecourses.com/activity/p/59673/ Sun, 25 Oct 2026 22:15:17 -0400 @aca I agree with your point about the root cause still being in the process, and I think high defect rates should absolutely be treated as a warning for the quality assurance system. A high defect rate means the process…   Read more»

]]> f0bf4f80f9c8d52783dd72441a8b09af enzo.1216 replied to the topic "AI vs Human Judgment in QA : Who Makes the Final Decision ?" - https://medicaldevicecourses.com/activity/p/59672/ Sun, 25 Oct 2026 22:11:38 -0400 @aca I agree with you, and my answer to your question is yes. I think companies should define risk levels ahead of time that require a second review when an AI system and a QA professional disagree. Without them, the…   Read more»

]]> da03dd077d04257b2200e136b3e04162 Sid replied to the topic "AI vs Human Judgment in QA : Who Makes the Final Decision ?" - https://medicaldevicecourses.com/activity/p/58878/ Sun, 04 Oct 2026 23:17:39 -0400 @aca In my opinion, having a tiered second review has merit and is consistent with how regulators view software in quality systems. The greater the impact of the AI tool output on patient safety or product quality, the more scrutiny…   Read more»

]]> f20ee3f7d9172fcfeb1b7821f161883d Sid replied to the topic "Should AI-Based Medical Devices Require the Same Regulatory Approach as Traditional Medical Devices ?" - https://medicaldevicecourses.com/activity/p/58800/ Mon, 28 Sep 2026 03:22:20 -0400 @aca I agree with your point that AI-enabled medical systems don’t need to submit entirely new documentation each time there is an update. I think that the degree to which the system must be tested depends on how substantial the…   Read more»

]]> b88c92f20b5863e8a40b8c2f3e0c59eb Ehab B. replied to the topic "Navigating Design History and Project Delivery" - https://medicaldevicecourses.com/activity/p/41569/ Mon, 23 Feb 2026 01:20:53 -0500 @aca your challenging of the idea that the DHF is the PM’s ultimate deliverable. If a PM’s mindset becomes to produce a perfect DHF, they risk placing too much focus on compliance instead of acting as a proper strategic leader….   Read more»

]]> 69e31eb4de9e52eef9c7920db2beb3c1 Ehab B. replied to the topic "PM Problem Involving Pre-clinical Trial Results and Market Entry Deadlines" - https://medicaldevicecourses.com/activity/p/40704/ Mon, 16 Feb 2026 01:33:43 -0500 @aca You raise an interesting issue here, as this is not just a technical setback but a design control and traceability event. With a high risk device like the stent, dissolution rate is not a secondary parameter, due to its…   Read more»

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