Medical Device Courses | ATMEH.NJIT | Activity https://medicaldevicecourses.com/members/atmeh-njit/activity/ Activity feed for ATMEH.NJIT. Sat, 16 May 2026 10:34:20 -0400 https://buddypress.org/?v= en-US 30 hourly 2 0ad91bd9a580b0c810d9829890cd4e4d ATMEH.NJIT posted a new topic "When Mitigation Becomes Its Own Risk!" - https://medicaldevicecourses.com/activity/p/33690/ Sun, 16 Nov 2025 06:21:43 -0500 Ever notice how some “risk controls” end up creating new risks? You add one more safety feature, and suddenly the design is twice as complex and harder to use.   How do you decide when a mitigation effort has gone too…   Read more»

]]> 7bcee0e7e15d93c0526b6d49f4400734 ATMEH.NJIT liked forum post "Are We Over-Relying on FMEAs?" - https://medicaldevicecourses.com/activity/p/33689/ Sun, 16 Nov 2025 06:11:09 -0500 b0beabb5da2bd1b6e73178fe7207f37f ATMEH.NJIT liked forum post "Are We Over-Relying on FMEAs?" - https://medicaldevicecourses.com/activity/p/33688/ Sun, 16 Nov 2025 06:11:02 -0500 a9ab393846598ed3f4234f94402de72c ATMEH.NJIT posted a new topic "Can Risk Really Be Eliminated — or Only Managed?" - https://medicaldevicecourses.com/activity/p/33672/ Fri, 14 Nov 2025 19:57:30 -0500 In medical device development, we talk a lot about “risk mitigation,” but rarely about whether total risk elimination is even possible. For example, implantable devices like pacemakers or insulin pumps always carry some residual risk no matter how much testing…   Read more»

]]> 15cd52ce98e35ab0a9de86a2ec05afb1 ATMEH.NJIT posted a new topic "Are We Over-Relying on FMEAs?" - https://medicaldevicecourses.com/activity/p/33671/ Fri, 14 Nov 2025 19:52:39 -0500 Failure Mode and Effects Analysis (FMEA) is the go-to tool for risk analysis in most medical device companies, but does it make us too mechanical in our approach? Real-world failures — like software bugs or user errors — often arise…   Read more»

]]> c2223e42589e404f05cfd02aad77441c ATMEH.NJIT liked forum post "Can Verification Cause a Tragedy?" - https://medicaldevicecourses.com/activity/p/33669/ Fri, 14 Nov 2025 19:37:41 -0500 2b9ef2551d8964179a2aaf12da0ebab7 ATMEH.NJIT liked forum post "Can Verification Cause a Tragedy?" - https://medicaldevicecourses.com/activity/p/33668/ Fri, 14 Nov 2025 19:37:37 -0500 000401ebb5e5804615438c2bfd213df9 ATMEH.NJIT liked forum post "Can Verification Cause a Tragedy?" - https://medicaldevicecourses.com/activity/p/33667/ Fri, 14 Nov 2025 19:37:34 -0500 19f7b116096f1701ec56a1589b6c0746 ATMEH.NJIT liked forum post "Can Verification Cause a Tragedy?" - https://medicaldevicecourses.com/activity/p/33666/ Fri, 14 Nov 2025 19:37:32 -0500 c30a9765ead816f38f4698ebbedd8d17 ATMEH.NJIT liked forum post "Can Verification Cause a Tragedy?" - https://medicaldevicecourses.com/activity/p/33665/ Fri, 14 Nov 2025 19:37:22 -0500 46aa8c4e26210393ef4d49ff47b4ec71 ATMEH.NJIT liked forum post "Can Verification Cause a Tragedy?" - https://medicaldevicecourses.com/activity/p/33664/ Fri, 14 Nov 2025 19:37:21 -0500 c0c5aaaa68a15e8a5e7af33d56a48333 ATMEH.NJIT liked forum post "Can Verification Cause a Tragedy?" - https://medicaldevicecourses.com/activity/p/33663/ Fri, 14 Nov 2025 19:37:14 -0500 5e26b931d0174465a3b4a5adc5ff982d ATMEH.NJIT liked forum post "Can Verification Cause a Tragedy?" - https://medicaldevicecourses.com/activity/p/33662/ Fri, 14 Nov 2025 19:37:10 -0500 5257a90d45b029564c0fa195bea5b478 ATMEH.NJIT liked forum post "Can Verification Cause a Tragedy?" - https://medicaldevicecourses.com/activity/p/33661/ Fri, 14 Nov 2025 19:37:04 -0500 fe639f82225fded1b9b8cf53df448ab4 ATMEH.NJIT liked forum post "Efficiency or Compliance?" - https://medicaldevicecourses.com/activity/p/33660/ Fri, 14 Nov 2025 19:36:42 -0500 90861098643fa31a5f461d40f862b27d ATMEH.NJIT liked forum post "Efficiency or Compliance?" - https://medicaldevicecourses.com/activity/p/33659/ Fri, 14 Nov 2025 19:36:39 -0500 1ffb39bffb1de224c854336039f06bcc ATMEH.NJIT liked forum post "Efficiency or Compliance?" - https://medicaldevicecourses.com/activity/p/33658/ Fri, 14 Nov 2025 19:36:36 -0500 e3b5263d084f822e66e894a295a68de1 ATMEH.NJIT liked forum post "Efficiency or Compliance?" - https://medicaldevicecourses.com/activity/p/33657/ Fri, 14 Nov 2025 19:36:35 -0500 bb82dd9e77edc016bd86e27d841f6039 ATMEH.NJIT liked forum post "Efficiency or Compliance?" - https://medicaldevicecourses.com/activity/p/33656/ Fri, 14 Nov 2025 19:36:33 -0500 0097d9602df0ce8602ad33109fcb33e7 ATMEH.NJIT liked forum post "Efficiency or Compliance?" - https://medicaldevicecourses.com/activity/p/33655/ Fri, 14 Nov 2025 19:36:31 -0500 4e6dd4b359689f8473cda35ed6de6b52 ATMEH.NJIT liked forum post "Efficiency or Compliance?" - https://medicaldevicecourses.com/activity/p/33654/ Fri, 14 Nov 2025 19:36:27 -0500 8ae2ce02dda99d61f197341a6d07e18f ATMEH.NJIT liked forum post "Efficiency or Compliance?" - https://medicaldevicecourses.com/activity/p/33653/ Fri, 14 Nov 2025 19:36:25 -0500 7fc5b8a4bff74c8d81a52491db69a04c ATMEH.NJIT liked forum post "Efficiency or Compliance?" - https://medicaldevicecourses.com/activity/p/33652/ Fri, 14 Nov 2025 19:36:23 -0500 e6861b79097be13577afaa523642a170 ATMEH.NJIT posted a new topic "Can Verification Cause a Tragedy?" - https://medicaldevicecourses.com/activity/p/33530/ Thu, 06 Nov 2025 02:49:00 -0500 The Therac-25 radiation therapy machine (1985–1987) caused multiple fatal overdoses due to software design flaws and inadequate verification. Engineers reused old code and skipped redundancy testing — clear failures of design controls we take for granted today. This case shaped…   Read more»

]]> 15be09f48b60e7c9645afe3a32c48482 ATMEH.NJIT posted a new topic "When Design Controls Fail — The DePuy Hip Recall" - https://medicaldevicecourses.com/activity/p/33529/ Thu, 06 Nov 2025 02:40:02 -0500 The DePuy ASR XL hip implant recall (2010) shows how gaps in design controls can lead to massive patient harm. Despite passing early testing, design verification, and post-market surveillance failed to catch issues like metal debris generation and tissue necrosis…   Read more»

]]> 8e0661deb0bce5f54a172ee90b6c32d0 ATMEH.NJIT liked forum post "Updating documentation or information overload?" - https://medicaldevicecourses.com/activity/p/33528/ Thu, 06 Nov 2025 02:24:21 -0500 a64e55506ace3dfb5ded1a15dbabf4ca ATMEH.NJIT liked forum post "Updating documentation or information overload?" - https://medicaldevicecourses.com/activity/p/33527/ Thu, 06 Nov 2025 02:24:16 -0500 8c89aa5c3334efafaf615347079826de ATMEH.NJIT liked forum post "Updating documentation or information overload?" - https://medicaldevicecourses.com/activity/p/33526/ Thu, 06 Nov 2025 02:23:50 -0500 9ea88210839dc97de51cbb8ccf86b22f ATMEH.NJIT liked forum post "User Needs vs. Business Goals — Who Wins in Design?" - https://medicaldevicecourses.com/activity/p/33525/ Thu, 06 Nov 2025 02:23:20 -0500 37126b44aa73cbfc49e60f9827cc22ed ATMEH.NJIT liked forum post "User Needs vs. Business Goals — Who Wins in Design?" - https://medicaldevicecourses.com/activity/p/33524/ Thu, 06 Nov 2025 02:23:13 -0500 ba40f976bf0f0f852bd6364141efa9f2 ATMEH.NJIT posted a new topic "Updating documentation or information overload?" - https://medicaldevicecourses.com/activity/p/33495/ Tue, 04 Nov 2025 18:40:27 -0500 The lecture emphasized that documents like the DDP are “living documents.” This continuous update process helps ensure design alignment as the project evolves. However, constant updates can also create confusion and documentation fatigue. How can organizations balance maintaining up-to-date documentation…   Read more»

]]> 32458ecdd30b20bb07f2852caa7850e6 ATMEH.NJIT posted a new topic "Efficiency or Compliance?" - https://medicaldevicecourses.com/activity/p/33494/ Tue, 04 Nov 2025 18:36:00 -0500 Sometimes it feels like design controls exist mainly to satisfy regulators rather than to improve design efficiency. Yet, when applied properly, they create structure, traceability, and accountability that benefit the entire team. Do you think companies truly use design controls…   Read more»

]]> 25297dc830e25bd3a1179a4089e8de97 ATMEH.NJIT liked forum post "User Needs vs. Business Goals — Who Wins in Design?" - https://medicaldevicecourses.com/activity/p/33493/ Tue, 04 Nov 2025 18:26:37 -0500 f01f9ad136551fe79eaecec0aafd9f85 ATMEH.NJIT liked forum post "User Needs vs. Business Goals — Who Wins in Design?" - https://medicaldevicecourses.com/activity/p/33492/ Tue, 04 Nov 2025 18:26:35 -0500 55ee2fb529101945b7cfbd6c85151a7e ATMEH.NJIT liked forum post "User Needs vs. Business Goals — Who Wins in Design?" - https://medicaldevicecourses.com/activity/p/33491/ Tue, 04 Nov 2025 18:26:32 -0500 5a23ec4a0cfdc7200d5467edc2fe2025 ATMEH.NJIT liked forum post "User Needs vs. Business Goals — Who Wins in Design?" - https://medicaldevicecourses.com/activity/p/33490/ Tue, 04 Nov 2025 18:26:29 -0500 30ad066b3024d434bfcee9d6682493f6 ATMEH.NJIT liked forum post "User Needs vs. Business Goals — Who Wins in Design?" - https://medicaldevicecourses.com/activity/p/33489/ Tue, 04 Nov 2025 18:26:26 -0500 67569e9b4903dff5412bcb605a43c985 ATMEH.NJIT liked forum post "User Needs vs. Business Goals — Who Wins in Design?" - https://medicaldevicecourses.com/activity/p/33488/ Tue, 04 Nov 2025 18:26:24 -0500 d1e6c0d9d48b62c795671c9a7d053bb1 ATMEH.NJIT liked forum post "User Needs vs. Business Goals — Who Wins in Design?" - https://medicaldevicecourses.com/activity/p/33487/ Tue, 04 Nov 2025 18:26:21 -0500 d0dceb085c121291f5e2165fb066d64a ATMEH.NJIT liked forum post "Verification vs. Validation — Do We Really Need Both?" - https://medicaldevicecourses.com/activity/p/33486/ Tue, 04 Nov 2025 18:25:51 -0500 7b9a396359d686ad03f4f949a9410804 ATMEH.NJIT liked forum post "Verification vs. Validation — Do We Really Need Both?" - https://medicaldevicecourses.com/activity/p/33485/ Tue, 04 Nov 2025 18:25:46 -0500 f8853c05c75f1cd7b374861f066a0d95 ATMEH.NJIT liked forum post "Verification vs. Validation — Do We Really Need Both?" - https://medicaldevicecourses.com/activity/p/33484/ Tue, 04 Nov 2025 18:25:43 -0500 4381840d704b1d28c74f731c4d081e93 ATMEH.NJIT liked forum post "Verification vs. Validation — Do We Really Need Both?" - https://medicaldevicecourses.com/activity/p/33483/ Tue, 04 Nov 2025 18:25:39 -0500 213bdbe48f2e5100c1d136944ca4a72d ATMEH.NJIT liked forum post "Verification vs. Validation — Do We Really Need Both?" - https://medicaldevicecourses.com/activity/p/33482/ Tue, 04 Nov 2025 18:25:34 -0500 d93c54c53949f2b2537cf7e7d01c38a7 ATMEH.NJIT liked forum post "Verification vs. Validation — Do We Really Need Both?" - https://medicaldevicecourses.com/activity/p/33481/ Tue, 04 Nov 2025 18:25:32 -0500 ab066281f434bfb189452680acf2c97b ATMEH.NJIT liked forum post "Do Design Controls Help Innovation or Slow It Down?" - https://medicaldevicecourses.com/activity/p/33438/ Sun, 02 Nov 2025 15:50:42 -0500 05d059fbe210d48aa6816a9b678ee3be ATMEH.NJIT liked forum post "Do Design Controls Help Innovation or Slow It Down?" - https://medicaldevicecourses.com/activity/p/33437/ Sun, 02 Nov 2025 15:50:17 -0500 b70a5f07b35285605241ee6d686c6b95 ATMEH.NJIT liked forum post "Do Design Controls Help Innovation or Slow It Down?" - https://medicaldevicecourses.com/activity/p/33436/ Sun, 02 Nov 2025 15:50:03 -0500 aba734dbcb55dbff89fa0d170ed97019 ATMEH.NJIT liked forum post "Do Design Controls Help Innovation or Slow It Down?" - https://medicaldevicecourses.com/activity/p/33435/ Sun, 02 Nov 2025 15:49:59 -0500 52343070ca8a8f033078be29b6ca5ad1 ATMEH.NJIT posted a new topic "Verification vs. Validation — Do We Really Need Both?" - https://medicaldevicecourses.com/activity/p/33434/ Sun, 02 Nov 2025 15:49:51 -0500 Design verification checks if we built the product right, while validation checks if we built the right product for the user. Both are required, but they often overlap in testing and documentation. Is it really necessary to have both processes…   Read more»

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