BEGIN:VCALENDAR
PRODID:NingEventWidget-v1
VERSION:2.0
METHOD:PUBLISH
BEGIN:VTIMEZONE
TZID:America/New_York
X-LIC-LOCATION:America/New_York
BEGIN:DAYLIGHT
TZOFFSETFROM:-0500
TZOFFSETTO:-0400
TZNAME:EDT
DTSTART:19700308T020000
RRULE:FREQ=YEARLY;BYMONTH=3;BYDAY=2SU
END:DAYLIGHT
BEGIN:STANDARD
TZOFFSETFROM:-0400
TZOFFSETTO:-0500
TZNAME:EST
DTSTART:19701101T020000
RRULE:FREQ=YEARLY;BYMONTH=11;BYDAY=1SU
END:STANDARD
END:VTIMEZONE
BEGIN:VEVENT
UID:2140535:Event:67013
DTSTAMP:20260406T090800Z
SUMMARY:Webinar on Design Verification, Validation and Testing for Med
 ical Devices
DESCRIPTION:Description :\nDesign Control is an integral part of any q
 uality system in regulated industries. FDA Quality System regulation, 
 Quality System Inspection Techniques (QSR and QSIT) and ISO 13485 have
  specific product verification and validation requirements that must b
 e fulfilled in the medical device industry. FDA is getting more and mo
 re stringent about product design requirements for risk management and
  to fulfill its mandate for safety and efficacy of all medical devices
 . The design controls are now being expected from outside equipment ma
 nufacturers (OEM) and suppliers to the medical device industry. This w
 ebinar will educate you on the key areas that you need to focus on to 
 fulfill the design control requirements for your medical device at var
 ious phases of your product development.\nAreas Covered in the Session
  :\nProduct development process overview\nApplicable design verificati
 on and validation requirements\nTesting requirements including the per
 tinent ISO guidelines\nTranslation of user requirements into design in
 puts and role of testing and regulatory requirements\nFocusing on crit
 ical to customer and critical to quality requirements\nDesign verifica
 tion and design validation activity cycles\nTraceability and risk mana
 gement at all stages\nDesign outputs and documentation in DMR (Device 
 Master Records) and DHR (Device History Records)\nProof for how design
  outputs meet functional and operational requirements\nCompatibility o
 f the design with components and other accessories\nTest requirements 
 to fulfil acceptance criteria for final products\nHow to withstand reg
 ulatory scrutiny\nHow are changes and their effects controlled and doc
 umented during the device life cycle?\nSummary\nWho Will Benefit:\nSen
 ior management\nMiddle management\nResearch & Development\nQuality Eng
 ineers\nManufacturing Engineers\nRegulatory Affairs Professionals\nQua
 lity Assurance & Quality Control Personnel\nDevice Design Team\nDevice
  Development Team\nDevice Manufacturing Team\nVerification and/or Vali
 dation planning, execution and documentation for devices.\nStartup Com
 pany Leaders\n\nFor more information visit https://medtechiq.ning.com/
 events/webinar-on-design-verification-validation-and-testing-for-medic
 -1
DTSTART;TZID=America/New_York:20151014T130000
DTEND;TZID=America/New_York:20151014T140000
CATEGORIES:webinar
LOCATION:Online
WEBSITE:https://compliancetrainings.com/SiteEngine/ProductDetailView.a
 spx?id=MD1690
URL:https://compliancetrainings.com/SiteEngine/ProductDetailView.aspx?
 id=MD1690
CONTACT:4169154458
ORGANIZER;CN=compliancetrainings:https://medtechiq.ning.com/profile/co
 mpliancetrainings
ATTACH;FMTTYPE="image/jpeg":
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN=complianc
 etrainings:https://medtechiq.ning.com/profile/compliancetrainings
END:VEVENT
END:VCALENDAR