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DESCRIPTION:SPEAKER: Luis Jimenez\n\nThe rapidly changing technologies and 
 access to software through connected platforms have blurred the lines betw
 een consumer and medical products. This has historically resulted in some 
 challenges for healthcare regulators and industry to recognize software as
  medical devices (SaMDs) and applicable regulatory requirements. The COVID
 -19 pandemic has also affected these products in more than one way includi
 ng: demand\, regulatory deadlines and overall impact to healthcare.\n\nDur
 ing this presentation we will cover:\n\n- Impact that Covid-19 is having t
 o these types of devices and possible Emergency Use Authorization (EUA) pa
 thways\n\n- Specific regulatory challenges that the non-physical nature of
  software raises\n\n- Review of the definition and distinction between a S
 aMD and medical device software\n\n- International Medical Device Regulato
 rs Forum (IMDRF) recent developments\n\n- EU Medical Device Regulation (MD
 R) required changes\n\n- Discussion of FDA’s pre-certification program f
 or SaMD development\n\n- Requirements for Quality Management System and ke
 y characteristics for SaMDs\n\n- Review of IEC 62304- Software Lifecycle P
 rocess Standard and key considerations for Design History File\n\n- Clinic
 al Evaluation considerations of SaMDs\n\nThroughout the presentation\, we 
 will highlight recent regulatory changes as they apply to Medical Device s
 oftware and how businesses can best prepare for upcoming regulatory submis
 sions.\n\nCo-sponsored by: A Winsor Brown\n\nSpeaker(s): Luis Jimenez\, \n
 \nAgenda: \n6:30 - 6:45pmPST - Welcome\, Introduction\n\n6:45 - 8:00pm PST
  - Technical Talk by Luis Jimenez\n\n8:00 - 8:30pm PST - Q &amp; A\n\nIrvine\,
  California\, United States
LOCATION:Irvine\, California\, United States
ORGANIZER:goradatta@ieee.org
SEQUENCE:10
SUMMARY:OC EMBS: Regulatory Framework for Software as a Medical Device (SaM
 D) and Medical Device Software (2020 and Covid-19 Pandemic Update)
URL;VALUE=URI:https://events.vtools.ieee.org/m/236636
X-ALT-DESC:Description: &lt;br /&gt;&lt;p&gt;&lt;span style=&quot;font-size: 14pt\;&quot;&gt;&lt;strong&gt;SP
 EAKER: Luis Jimenez&lt;/strong&gt;&lt;/span&gt;&lt;/p&gt;\n&lt;p&gt;The rapidly changing technolog
 ies and access to software through connected platforms have blurred the li
 nes between consumer and medical products. This has historically resulted 
 in some challenges for healthcare regulators and industry to recognize sof
 tware as medical devices (SaMDs) and applicable regulatory requirements. T
 he COVID-19 pandemic has also affected these products in more than one way
  including: demand\, regulatory deadlines and overall impact to healthcare
 .&lt;/p&gt;\n&lt;p&gt;&amp;nbsp\;&lt;/p&gt;\n&lt;p&gt;During this presentation we will cover:&lt;/p&gt;\n&lt;p&gt;
 - Impact that Covid-19 is having to these types of devices and possible Em
 ergency Use Authorization (EUA) pathways&lt;/p&gt;\n&lt;p&gt;- Specific regulatory cha
 llenges that the non-physical nature of software raises&lt;/p&gt;\n&lt;p&gt;- Review o
 f the definition and distinction between a SaMD and medical device softwar
 e&lt;/p&gt;\n&lt;p&gt;- International Medical Device Regulators Forum (IMDRF) recent d
 evelopments&lt;/p&gt;\n&lt;p&gt;- EU Medical Device Regulation (MDR) required changes&lt;
 /p&gt;\n&lt;p&gt;- Discussion of FDA&amp;rsquo\;s pre-certification program for SaMD de
 velopment&lt;/p&gt;\n&lt;p&gt;- Requirements for Quality Management System and key cha
 racteristics for SaMDs&lt;/p&gt;\n&lt;p&gt;- Review of IEC 62304- Software Lifecycle P
 rocess Standard and key considerations for Design History File&lt;/p&gt;\n&lt;p&gt;- C
 linical Evaluation considerations of SaMDs&lt;/p&gt;\n&lt;p&gt;&amp;nbsp\;&lt;/p&gt;\n&lt;p&gt;Through
 out the presentation\, we will highlight recent regulatory changes as they
  apply to Medical Device software and how businesses can best prepare for 
 upcoming regulatory submissions.&lt;/p&gt;&lt;br /&gt;&lt;br /&gt;Agenda: &lt;br /&gt;&lt;p&gt;6:30 - 6:
 45pmPST - Welcome\, Introduction&lt;/p&gt;\n&lt;p&gt;6:45 - 8:00pm PST - Technical Tal
 k by Luis Jimenez&lt;/p&gt;\n&lt;p&gt;8:00 - 8:30pm PST - Q &amp;amp\; A&lt;/p&gt;
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