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DTSTAMP:20260525T130339Z
SUMMARY:Medical Device Software Per IEC 62304
DESCRIPTION:Overview\nThis course is essential for Medical Device comp
 anies interested in submitting software enabled medical Devices or Sof
 tware as a Medical Device to the FDA for 510K approval. One of the big
 gest risks most company's face when submitting their device for approv
 al is finding out after seven or more months of waiting that the 510K 
 has been denied because the software portion of the submittal is inade
 quate and not compliant. They also face potential audit risk which mig
 ht prevent them from selling their approved product if they have been 
 found to not have an IEC62304 Compliant Software Quality System.\nWhy 
 should you Attend\nDeveloping software for medical devices can be a ch
 allenge especially if the device is complicated. You do not know if it
  is safe enough. You do not know if it tested enough. You do not know 
 if the FDA will consider it for suitability for a 510K. Should your so
 ftware cause harm to someone you don't know if you are protected from 
 liability should your software fail.\nCompliance with IEC62304 is key 
 to ensure your software has been developed to the highest level of saf
 ety. Developing software based on the standard shows one way to indica
 te an intent to ensure the safety of your product. Gives you a framewo
 rk to ensure you are developing and testing to consistent and stringen
 t standard. Demonstrating compliance with the standard will be apparen
 t in your submission and will be one way to ensure acceptance by the F
 DA.\nAreas Covered in the Session\n\n\nWhy is having an IEC62304 Compl
 iant Software Quality System important to both developing your softwar
 e for 510K approval and how you can be putting your company at risk po
 st-approval if you do not have a compliant system in place\nWhat is IE
 C62304 and how does it differ from other Compliance Standards such as 
 ISO13485\nWhat are the elements that constitute an IEC62304 Compliant 
 System?\nBenefits of developing to an IEC62304 standard\nWhat are the 
 components of the Software Lifecycle\nWhat are the major Software Work
  Products developed to the standard?\nHow it fits in with a Company's 
 Standard Quality Process\nWhat are the legal consequences for the comp
 any with the submittal if the company does not adhere to the Guidance\
 nOne of the most common reasons that a Software Enabled Medical Device
  is denied a 510K is because the Guidance has not been followed\nWhat 
 are the potential audit consequences if the Company does not have an I
 EC62304 Compliance Quality System in place\nUnderstand the regulatory 
 need for IEC 62304 Guidance as it relates to submitting a 510K for Sof
 tware Enabled Medical Devices\nWhat constitutes compliance with the St
 andard\nWhat areas does the Guidance Address\nWhat are the legal conse
 quences for the company with the submittal if the company does not adh
 ere to the Guidance\n\nWho Will Benefit\n\nManagers, Supervisors, Dire
 ctors, and Vice-Presidents in the areas of:\n\nRegulatory\nQuality\nVi
 ce President of Compliance and Regulatory\nCompliance Expert\nSoftware
  Engineer\nSoftware Engineering Manager\nSoftware Compliance Engineer\
 nMedical Device Software Engineer\n\n\nFor more information visit http
 s://medtechiq.ning.com/events/medical-device-software-per-iec-62304
DTSTART;TZID=America/New_York:20190205T100000
DTEND;TZID=America/New_York:20190205T110000
CATEGORIES:webinar
LOCATION:Online
WEBSITE:https://www.traininng.com/webinar/medical-device-software-per-
 iec-62304--200610live?medtechiq_seo
URL:https://www.traininng.com/webinar/medical-device-software-per-iec-
 62304--200610live?medtechiq_seo
CONTACT:8003851607
ORGANIZER:Traininng.com LLC
ATTACH;FMTTYPE="image/jpeg":
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN="Joseph W
 ilcox":https://medtechiq.ning.com/profile/JosephWilcox
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