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DTSTART:20210314T030000
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DTSTAMP:20210428T160021Z
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DTSTART;TZID=US/Eastern:20210503T130000
DTEND;TZID=US/Eastern:20210506T160000
DESCRIPTION:This course has been canceled and will be rescheduled in the fa
 ll.\n\nThis course will be presented with a live instructor using web-meet
 ing software. The course content will be covered in 4 sessions presented o
 ver four days.\n\nCOURSE SUMMARY: Developing software in compliance with t
 he FDA Design Control regulation\, changing FDA guidance documents and lat
 est international standards is challenging. This intensive course provides
  practical solutions and suggestions for developing software in a manner t
 hat meets applicable FDA regulations\, guidance documents and internationa
 l standards\, such as IEC-62304:2015. The focus is on interpreting Design 
 Controls for software. Each section of the Design Controls regulation (820
 .30) is discussed from the perspective of software development. Discussion
 s on key topics such as Software Requirements\, Traceability\, Design Revi
 ews\, Software Verification & Validation and Risk Management (including re
 cently updated standards ISO-14971:2019 and EN-14971:2019) are included. A
 lso discussed are FDA requirements for validation of software development 
 tools and software used in Manufacturing and Quality Systems. Also discuss
 ed are recent FDA Guidance Documents on Cybersecurity\, Mobile Apps\, and 
 Usability.\n\nTHIS COURSE IS INTENDED FOR…Software engineers\, project m
 anagers\, quality managers\, software quality professionals\, RA/QA staff\
 , and anyone who needs to develop cost-effective processes and procedures 
 that will enable their organizations to deliver high quality software-base
 d medical devices that comply with FDA regulations and international stand
 ards. This course is also appropriate for people who are new to the medica
 l device industry. Course notes\, access to an extensive collection of ref
 erence documents and a training certificate are provided.\n\nCOURSE OUTLIN
 E: This course will be presented with a live instructor using web-meeting 
 software. The course content will be covered in 4 sessions\n\nSpeaker(s): 
 Steve R. Rakitin\, \n\nVirtual: https://events.vtools.ieee.org/m/249105
LOCATION:Virtual: https://events.vtools.ieee.org/m/249105
ORGANIZER:ieeebostonsection@gmail.com
SEQUENCE:4
SUMMARY:Software Development for Medical Device Manufacturers - Canceled! 
URL;VALUE=URI:https://events.vtools.ieee.org/m/249105
X-ALT-DESC:Description: <br /><p>This course has been canceled and will be 
 rescheduled in the fall.</p>\n<p>This course will be presented with a live
  instructor using web-meeting software. The course content will be covered
  in <strong>4 sessions</strong> presented over four days.</p>\n<p><strong>
 COURSE SUMMARY:&nbsp\;&nbsp\;</strong>Developing software in compliance wi
 th the FDA Design Control regulation\, changing FDA guidance documents and
  latest international standards is challenging. This intensive course prov
 ides practical solutions and suggestions for developing software in a mann
 er that meets applicable FDA regulations\, guidance documents and internat
 ional standards\, such as&nbsp\;<strong>IEC-62304:2015</strong>. The focus
  is on <strong>interpreting</strong> <strong>Design Controls for software<
 /strong>. Each section of the Design Controls regulation (820.30) is discu
 ssed from the perspective of software development. Discussions on key topi
 cs such as Software Requirements\, Traceability\, Design Reviews\, Softwar
 e Verification &amp\; Validation and Risk Management (including recently u
 pdated standards&nbsp\;<strong>ISO-14971:2019</strong>&nbsp\;and&nbsp\;<st
 rong>EN-14971:2019</strong>) are included. Also discussed are FDA requirem
 ents for validation of software development tools and software used in Man
 ufacturing and Quality Systems. Also discussed are recent FDA Guidance Doc
 uments on <strong>Cybersecurity\, Mobile Apps\,&nbsp\;</strong>and&nbsp\;<
 strong>Usability.</strong></p>\n<p><strong>THIS COURSE IS INTENDED FOR&hel
 lip\;</strong>Software engineers\, project managers\, quality managers\, s
 oftware quality professionals\, RA/QA staff\, and anyone who needs to deve
 lop cost-effective processes and procedures that will enable their organiz
 ations to deliver high quality software-based medical devices that comply 
 with FDA regulations and international standards. This course is also appr
 opriate for people who are new to the medical device industry. Course note
 s\, access to an extensive collection of reference documents and a trainin
 g certificate are provided.&nbsp\;</p>\n<p><strong>COURSE OUTLINE:&nbsp\;&
 nbsp\;</strong>This course will be presented with a live instructor using 
 web-meeting software. The course content will be covered in <strong>4 sess
 ions</strong></p>
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