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UID:2140535:Event:63639
DTSTAMP:20260521T134345Z
SUMMARY:Webinar On Design Verification, Validation and Testing for Med
 ical Devices
DESCRIPTION:Design Control is an integral part of any quality system i
 n regulated industries. FDA Quality System regulation, Quality System 
 Inspection Techniques (QSR and QSIT) and ISO 13485 have specific produ
 ct verification and validation requirements that must be fulfilled in 
 the medical device industry. FDA is getting more and more stringent ab
 out product design requirements for risk management and to fulfill its
  mandate for safety and efficacy of all medical devices. The design co
 ntrols are now being expected from outside equipment manufacturers (OE
 M) and suppliers to the medical device industry. This webinar will edu
 cate you on the key areas that you need to focus on to fulfill the des
 ign control requirements for your medical device.\n \nAreas Covered i
 n the Session :\nProduct development process overview\nApplicable desi
 gn verification and validation requirements\nTesting requirements incl
 uding the pertinent ISO guidelines\nTranslation of user requirements i
 nto design inputs and role of testing and regulatory requirements\nFul
 filling critical to customer and critical to quality requirements\nDes
 ign verification and design validation activity cycles\nTraceability a
 nd risk management at all stages\nDesign outputs and documentation in 
 DMR (Device Master Records) and DHR (Device History Records)\nTest req
 uirements to fulfil acceptance criteria for final products\nHow to wit
 hstand regulatory scrutiny\nHow are changes and their effects controll
 ed and documented during the device life cycle?\nSummary\n \nWho Will
  Benefit:\nSenior management\nMiddle management\nResearch & Developmen
 t\nQuality Engineers\nManufacturing Engineers\nRegulatory Affairs Prof
 essionals\nQuality Assurance & Quality Control Personnel\nDevice Desig
 n Team\nDevice Development Team\nDevice Manufacturing Team\nVerificati
 on and/or Validation planning, execution and documentation for devices
 .\nStart up Company Leaders\nPrice Tags:\nLive\nSingle Live : For One 
 Participant\n$ 249\nCorporate Live : For Max. 10 Participants\n$ 899\n
 Recording\nSingle REC : For One Participant - Unlimited Access for 6 M
 onths\n$ 299\n\nFor more information visit https://medtechiq.ning.com/
 events/webinar-on-design-verification-validation-and-testing-for-medic
 al
DTSTART;TZID=America/New_York:20140613T130000
DTEND;TZID=America/New_York:20140613T141500
CATEGORIES:webinar
LOCATION:5939 Candlebrook Ct, Mississauga, ON L5V 2V5, Canada
WEBSITE:https://compliancetrainings.com/SiteEngine/ProductDetailView.a
 spx?id=MD1091
URL:https://compliancetrainings.com/SiteEngine/ProductDetailView.aspx?
 id=MD1091
CONTACT:4169154458
ORGANIZER:Compliance Trainings
ATTACH;FMTTYPE="image/jpeg":
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN=complianc
 etrainings:https://medtechiq.ning.com/profile/compliancetrainings
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