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DTSTART:19700308T020000
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UID:2140535:Event:78489
DTSTAMP:20260524T110145Z
SUMMARY:Webinar On \"Medical Device Human Factors Validation Testing F
 ollowing ISO 62366 and new FDA Guidance\"
DESCRIPTION:\nDescription :\nThis webinar will explain the procedure d
 escribed in ISO62366 and the 2016 FDA Guidance for a compliant human f
 actors/ usability validation. HF/U validation is very different from d
 evice validation. For example, success criteria is qualitative rather 
 than quantatative as is in device validation. Claiming success because
  eg. 95% of test participants did not commit a user error is not valid
 . Nor is 100% positive test results sufficient.Why you should attend :
 \nFollowing the implementation of the reults of a Human Factors/ Usabi
 lity study, a validation of the safety and effectiveness of the use of
  the device must be conducted. We will explain the FDA required number
  of validation participants from each \"distinct user population\". We
  will explain how to choose the tests to be conducted and the studies 
 that must be completed prior to the actual validation test. The post t
 est participant inquiry is critical to validation success. we will des
 cribe how to do this. handouts areusability validation tracking form,p
 rotocol form, and test results report form\n\n\n\n\nAreas Covered in t
 he Session :\n\nRequired number of participants\nQualitative success c
 riteria\nChoice of tasks to validate\nPost test participant inquiry.\n
 \nForms:\n\nUsability Validation Tracking Matrix\nValidation ProtocolĀ
  \nand Validation Test Results Report will be given asĀ  Handouts\n\n\
 n\n\n\nWho Will Benefit:\n\nDevelopment Engineers\nProduction Manageme
 nt\nQA/ QC personnel\nSoftware developers\nEngineering management\n\n\
 n\n\n\nAbout Speaker:\nEdwin Waldbusser retired from industry after 20
  years in management of development of medical device products and dev
 elopment of company Quality Systems. Products included IVD devices, ki
 dney dialysis systems and inhalation devices. QS experience includes d
 esign control, risk analysis, CAPA, software validation, supplier qual
 ification/ control and manufacturing/ non-conforming product programs.
 \n\n\n\n\n\n\nFor more information visit https://medtechiq.ning.com/ev
 ents/webinar-on-medical-device-human-factors-validation-testing
DTSTART;TZID=America/New_York:20180215T130000
DTEND;TZID=America/New_York:20180215T140000
CATEGORIES:online, "/", webinar
LOCATION:Online
WEBSITE:http://bit.ly/2C10SLM
URL:http://bit.ly/2C10SLM
CONTACT:1-844-216-5230
ORGANIZER;CN="Sam Miller":https://medtechiq.ning.com/profile/SamMiller
ATTACH;FMTTYPE="image/jpeg":http://storage.ning.com/topology/rest/1.0/
 file/get/2562016959?profile=original
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN="Sam Mill
 er":https://medtechiq.ning.com/profile/SamMiller
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