INDiE Med Tech | Jude | Activity https://indiemedtech.com/members/jshellito/activity/ Activity feed for Jude. Mon, 08 Jun 2026 12:40:44 -0400 https://buddypress.org/?v=2.14.0 en-US 30 hourly 2 4ce7d224fbe7076d826a194524ed497a Jude started the discussion eMDR Gateway set up in the forum Regulatory https://indiemedtech.com/groups/regulatory/forum/topic-discussion/emdr-gateway-set-up/ Tue, 03 Mar 2026 18:08:57 -0500 eMDR Gateway set up

My client has the need to set up and begin submitting MDR’s. The guidance mentions an ESG Next Gen gateway. I have never set this up. Does anyone have experience with this and can provide some pointers.

]]> 289c960e13ffd9bf83746140032609b9 Jude replied to the discussion IVDR Metrological Traceability in the forum Regulatory https://indiemedtech.com/groups/regulatory/forum/topic-discussion/ivdr-metrological-traceability/#post-4206 Wed, 04 Feb 2026 14:54:13 -0500 Reply to IVDR Metrological Traceability

Hi Ash can you be more specific as to what on the Medical Device requires Metrological Traceability ?

]]> 5564d74073a29f81ce024df52da9def0 Jude joined the group eQMS https://indiemedtech.com/news-feed/p/680/ Wed, 14 Jan 2026 22:32:56 -0500 0 7f6443ff7d4b7529aadf1f227f969de0 Jude joined the group Codon Partners Career Corner https://indiemedtech.com/news-feed/p/679/ Wed, 14 Jan 2026 22:32:39 -0500 0 0b2a261d7755ea1145291899ff74c5f8 Jude and Niki are now connected https://indiemedtech.com/news-feed/p/615/ Thu, 18 Dec 2025 17:04:14 -0500 0 4019757d65652a68bace204bf6d64bc5 Jude and Catherine are now connected https://indiemedtech.com/news-feed/p/605/ Wed, 17 Dec 2025 05:32:25 -0500 0 eec4556914d75369427ffe1e4cbf9e4b Jude replied to the discussion QMSR Transition: Medical Device File vs. DMR/DHF in the forum Quality https://indiemedtech.com/groups/quality/forum/topic-discussion/qmsr-transition-medical-device-file-vs-dmr-dhf/#post-4066 Thu, 13 Nov 2025 14:44:00 -0500 Reply to QMSR Transition: Medical Device File vs. DMR/DHF

Hi Holly, I would love to share the definition comparison. I am unable to upload to this site. Any help would be appreciated. TY

]]> 029e0d16d85b185898b056178cb42910 Jude replied to the discussion QMSR Transition: Medical Device File vs. DMR/DHF in the forum Quality https://indiemedtech.com/groups/quality/forum/topic-discussion/qmsr-transition-medical-device-file-vs-dmr-dhf/#post-4055 Mon, 03 Nov 2025 14:55:31 -0500 Reply to QMSR Transition: Medical Device File vs. DMR/DHF

Hi Holly, I think that would be a valuable tool to help facilitate common understanding of similar terms. I do think the transition to a common 13485 terminology may take years as these terms are well ingrained into corporate culture. Would you like me to put something together ?

]]> 32e55b2abb8b3239037a7780e101ea7f Jude updated their profile https://indiemedtech.com/news-feed/p/496/ Wed, 29 Oct 2025 14:23:06 -0400 0 add94de3927436c2828d11d53581ebb9 Jude replied to the discussion QMSR Transition: Medical Device File vs. DMR/DHF in the forum Quality https://indiemedtech.com/groups/quality/forum/topic-discussion/qmsr-transition-medical-device-file-vs-dmr-dhf/#post-3780 Wed, 15 Oct 2025 14:53:46 -0400 Reply to QMSR Transition: Medical Device File vs. DMR/DHF

Had a few minutes and thought I would add to the discussion.

Using consistent and accurate terminology is critical to assure a common understanding and alignment with regulatory authorities and within your organization. I have worked with clients that tend to create there own terminology and I can assure you it not only confuses…

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]]> c41d197f787737e9a5c0cafaa0cc8055 Jude joined the group Marketing and Business Development https://indiemedtech.com/news-feed/p/460/ Fri, 03 Oct 2025 15:26:59 -0400 0 a4ee35cbe50728eed1c82ebe505a587b Jude joined the group FDA https://indiemedtech.com/news-feed/p/444/ Wed, 24 Sep 2025 20:15:38 -0400 0 d1028309202afdef0a49688bcc4e92b6 Jude started the discussion Malaysia is now a MDSAP member in the forum Regulatory https://indiemedtech.com/groups/regulatory/forum/topic-discussion/malaysia-is-now-a-mdsap-member/ Tue, 23 Sep 2025 19:11:35 -0400 Malaysia is now a MDSAP member

Malaysia is now a MDSAP member – unable to post the link to the MDSAP site

]]> 994b6b0d56393805b6dce3df430921c8 Jude joined the group Quality https://indiemedtech.com/news-feed/p/440/ Tue, 23 Sep 2025 14:18:11 -0400 0 7384a7d2b7074b04ae56788cd82102df Jude and Daria are now connected https://indiemedtech.com/news-feed/p/410/ Thu, 11 Sep 2025 00:57:49 -0400 0 dfa4f662ebdf7dabcb032f6805a2b9d0 Jude joined the group Risk Management https://indiemedtech.com/news-feed/p/406/ Wed, 10 Sep 2025 13:58:23 -0400 0 3165de92c5221f30440a69d432023505 Jude joined the group Consulting https://indiemedtech.com/news-feed/p/405/ Wed, 10 Sep 2025 13:58:02 -0400 0 71d4860c70345641b0996588d2a82546 Jude posted a new activity comment https://indiemedtech.com/news-feed/p/395/#acomment-396 Tue, 09 Sep 2025 13:47:57 -0400 I did, I read an article about how consulting firms have promised a great deal regarding AI and then have provided little to no results. Although the Deloitte issue was an ERP system. I think the principle is the same overpromising and underdelivering. In the end I think the lawsuit will be dropped for additional support. But we will…

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In reply to - Holly posted an update in the group indieFeed

Did anyone see this? Zimmer Biomet sues Deloitte over disaster implementation of an enterprise resource planning software for $172M – this is pretty wild to see such […]

]]> 15067f4187080f729733e01a830b6342 Jude joined the group Regulatory https://indiemedtech.com/news-feed/p/385/ Fri, 05 Sep 2025 17:49:03 -0400 0 bd3156bc29532303f4a88c8f41caf3c7 Jude and Kimberly are now connected https://indiemedtech.com/news-feed/p/353/ Thu, 04 Sep 2025 17:50:26 -0400 0 4365f3a2067e6cee3c1d3802a271e5c0 Jude updated their profile https://indiemedtech.com/news-feed/p/351/ Thu, 04 Sep 2025 17:12:31 -0400 0 4fc5911025201b054d1190c7bc0a81b5 Jude and Theresa are now connected https://indiemedtech.com/news-feed/p/349/ Thu, 04 Sep 2025 14:54:30 -0400 0 a0a4c9713f5e71221e2cc2fb88093af9 Jude updated their profile https://indiemedtech.com/news-feed/p/329/ Tue, 02 Sep 2025 20:20:25 -0400 0 b7607cd76ee3d87b71ffde066c66c40b Jude and Felicia are now connected https://indiemedtech.com/news-feed/p/328/ Tue, 02 Sep 2025 17:26:58 -0400 0 6f1528684e0619ebc9be5ee46d0157ca Jude and Amie are now connected https://indiemedtech.com/news-feed/p/325/ Tue, 02 Sep 2025 16:13:32 -0400 0 6b2b01cb6f08c9474abfcc14d81b5de8 Jude and Jyothsna are now connected https://indiemedtech.com/news-feed/p/322/ Tue, 02 Sep 2025 15:34:22 -0400 0 38433970c436d554597f44039fc964d8 Jude and Melissa are now connected https://indiemedtech.com/news-feed/p/320/ Tue, 02 Sep 2025 15:19:22 -0400 0 dc7667e214e07d12b076700205c944c9 Jude updated their profile https://indiemedtech.com/news-feed/p/313/ Fri, 29 Aug 2025 19:33:35 -0400 0 da54e263e1d6d73d35e398bd142f09a1 Jude changed their profile photo https://indiemedtech.com/news-feed/p/312/ Fri, 29 Aug 2025 19:21:07 -0400 0 3cb87e024038347f5986db03c901554d Jude joined the group indieFeed https://indiemedtech.com/news-feed/p/310/ Fri, 29 Aug 2025 19:16:52 -0400 0