www.raps.org
Open in
urlscan Pro
45.60.124.90
Public Scan
Submitted URL: https://message.raps.org/MjU5LVdMVS04MDkAAAGJapUEjEjL4pHmiUM6eYJ3SJ1nrXBY6X-YFdWMAQjXk4Z9Is1Hgx9Qj8I3mKuiOYH9IMpWuMI=
Effective URL: https://www.raps.org/?mkt_tok=MjU5LVdMVS04MDkAAAGJapUEjFfxRnwRMoSgaNlu-WrT6D_aBdnyOa9A82jcGvdO3pB1Vn0EEp68_3hTa_qfpyc...
Submission: On January 19 via api from US — Scanned from DE
Effective URL: https://www.raps.org/?mkt_tok=MjU5LVdMVS04MDkAAAGJapUEjFfxRnwRMoSgaNlu-WrT6D_aBdnyOa9A82jcGvdO3pB1Vn0EEp68_3hTa_qfpyc...
Submission: On January 19 via api from US — Scanned from DE
Form analysis 1 forms found in the DOM
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<div class="svg-legend" aria-hidden="true">
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<defs>
<symbol id="icomoon-lock" viewBox="0 0 59.901 94.6">
<title>Lock</title>
<path
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<symbol id="icomoon-lock-alt" viewBox="0 0 18 28">
<title>Members Only</title>
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<symbol id="icomoon-close" viewBox="0 0 32 32">
<title>close</title>
<path d="M32 3.2l-3.2-3.2-12.8 12.8-12.8-12.8-3.2 3.2 12.8 12.8-12.8 12.8 3.2 3.2 12.8-12.8 12.8 12.8 3.2-3.2-12.8-12.8 12.8-12.8z"></path>
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<symbol id="icomoon-arrow-right" viewBox="0 0 32 32">
<title>arrow-right</title>
<path
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</symbol>
<symbol id="icomoon-cart" viewBox="0 0 32 32">
<title>cart</title>
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<symbol id="icomoon-search" viewBox="0 0 32 32">
<title>search</title>
<path
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<symbol id="icomoon-google-plus" viewBox="0 0 32 32">
<title>google-plus</title>
<path
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<symbol id="icomoon-facebook" viewBox="0 0 32 32">
<title>facebook</title>
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<symbol id="icomoon-twitter" viewBox="0 0 32 32">
<title>twitter</title>
<path
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<symbol id="icomoon-youtube" viewBox="0 0 32 32">
<title>youtube</title>
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<symbol id="icomoon-flickr" viewBox="0 0 32 32">
<title>flickr</title>
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</symbol>
<symbol id="icomoon-linkedin" viewBox="0 0 32 32">
<title>linkedin</title>
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<symbol id="icomoon-calendar" viewBox="0 0 20 20">
<title>calendar</title>
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<symbol id="icomoon-user" viewBox="0 0 32 32">
<title>user</title>
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<symbol id="icomoon-menu" viewBox="0 0 20 20">
<title>menu</title>
<path
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<symbol id="icomoon-menu-close" viewBox="0 0 20 20">
<title>menu-close</title>
<path
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<symbol id="icomoon-print" viewBox="0 0 32 32">
<title>print</title>
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<symbol id="icomoon-share" viewBox="0 0 32 32">
<title>share</title>
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<symbol id="icomoon-circle-down" viewBox="0 0 32 32">
<title>circle-down</title>
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<title>help</title>
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<symbol id="icomoon-briefcase" viewBox="0 0 32 32">
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<p class="re-auth-meta"> By <a href="https://connect.raps.org/profile?UserKey=40fbe166-41ef-4063-855f-68da2c564d5b">Anonymous Member</a><br> 19 January 2023 7:13 PM
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<a href="https://connect.raps.org/discussion/changing-ipc-sampling-after-validation#bme9a2038d-f898-431e-880b-26d33a83c39a"><strong>Changing IPC sampling after validation</strong></a>
<p class="lineheightreduced margintop"> This message was posted by a user wishing to remain anonymous Hello Everyone, I would like to get some clarifications about sampl...</p>
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<p class="re-auth-meta"> By <a href="https://connect.raps.org/profile?UserKey=92de798f-5fd2-4642-a008-37fc3835b990">Barbara Hutcherson</a><br> 19 January 2023 7:03 PM
<br><a href="http://connect.raps.org/communities/community-home/digestviewer?ListKey=48524eba-e684-437f-85bd-b95d5047f829"><b>Regulatory Open Forum</b></a></p>
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<a href="https://connect.raps.org/discussion/raps-first-full-time-employee-in-europe-is-a-familiar-face#bmbc8443f9-5223-415d-bd3c-0185cb789d8e"><strong>RE: RAPS' first full-time employee in Europe is a familiar face</strong></a>
<p class="lineheightreduced margintop"> So very happy to have Kim on the RAPS team making and maintaining vital connections in Europe. She has alr...</p>
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<p class="re-auth-meta"> By <a href="https://connect.raps.org/profile?UserKey=40fbe166-41ef-4063-855f-68da2c564d5b">Anonymous Member</a><br> 19 January 2023 7:00 PM
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<div class="clear margin-bottom-reg"></div><a href="https://connect.raps.org/discussion/can-an-auditor-audit-device-in-rd#bm804b57ad-e134-40e2-9910-eb231d77f896"><strong>Can an auditor audit device in R&D?</strong></a>
<p class="lineheightreduced margintop"> This message was posted by a user wishing to remain anonymous Can an auditor ask to see records for a device in the R&D stage? (...</p>
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<p class="re-auth-meta"> By <a href="https://connect.raps.org/profile?UserKey=32869250-ffe7-499e-89b6-771121f4b762">Sravan Kumar Manchikanti, RAC</a><br> 19 January 2023 6:41 PM
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<a href="https://connect.raps.org/discussion/labelling-requirements-for-medical-devices-in-india#bm9bacd2b3-8f91-4ce3-96ec-0185cb558baf"><strong>RE: Labelling Requirements for Medical Devices in India</strong></a>
<p class="lineheightreduced margintop"> Hi Magdalena, Manufacturing date needs to be added separately and must be printed in indelible ink on the label, ...</p>
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<p class="re-auth-meta"> By <a href="https://connect.raps.org/profile?UserKey=1b7baa4f-d0a4-4d8d-9900-daae1f40f300">Kara Budor</a><br> 19 January 2023 6:24 PM
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<a href="https://connect.raps.org/discussion/cer-equivalence-and-clinical-evidence#bm47552a98-d344-445f-a9ca-ca9a029c6e44"><strong>RE: CER , equivalence and clinical evidence</strong></a>
<p class="lineheightreduced margintop"> Hi Anonymous, For EU CERs, prior generation devices do not need to be identified as equivalent devices unless you want to id...</p>
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">
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19 JANUARY 2023 | BY NICK PAUL TAYLOR
EURO ROUNDUP: SWISSMEDIC RESPONDS TO EU PAPER ON AVOIDING MEDICAL DEVICE SUPPLY
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OIG REPORT HIGHLIGHTS SHORTCOMINGS IN FDA’S IT ACQUISITION PROCEDURES
The US Department of Health and Human Services (HHS) Office of Inspector General
(OIG) is calling on the Food and Drug Administratio...
18 JANUARY 2023 | BY SHAWN M. SCHMITT
ADVOCACY GROUPS, ADVAMED VIE FOR NEXT PHASE OF TAP PILOT
Medical devices that treat brain diseases and disorders should be the next
products to be accepted into a US Food and Drug Administr...
18 JANUARY 2023 | BY RYAN CONNORS
WHY KIM YOUNG JOINED THE RAPS’ STAFF AND WHY SHE WANTS YOU TO EMAIL HER
RAPS’ first full-time European employee explains the path that led her to RAPS,
what other regulatory professionals should know abou...
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REGULATORY EXCHANGE »
More RegExAll
By Anonymous Member
19 January 2023 7:13 PM
Regulatory Open Forum
Changing IPC sampling after validation
This message was posted by a user wishing to remain anonymous Hello Everyone, I
would like to get some clarifications about sampl...
Read more about
By Barbara Hutcherson
19 January 2023 7:03 PM
Regulatory Open Forum
RE: RAPS' first full-time employee in Europe is a familiar face
So very happy to have Kim on the RAPS team making and maintaining vital
connections in Europe. She has alr...
Read more about
By Anonymous Member
19 January 2023 7:00 PM
Regulatory Open Forum
Can an auditor audit device in R&D?
This message was posted by a user wishing to remain anonymous Can an auditor ask
to see records for a device in the R&D stage? (...
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By Sravan Kumar Manchikanti, RAC
19 January 2023 6:41 PM
Regulatory Open Forum
RE: Labelling Requirements for Medical Devices in India
Hi Magdalena, Manufacturing date needs to be added separately and must be
printed in indelible ink on the label, ...
Read more about
By Kara Budor
19 January 2023 6:24 PM
Regulatory Open Forum
RE: CER , equivalence and clinical evidence
Hi Anonymous, For EU CERs, prior generation devices do not need to be identified
as equivalent devices unless you want to id...
Read more about
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