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UID:2140535:Event:69775
DTSTAMP:20260513T185607Z
SUMMARY:Webinar on Test Methods and Standards for Design Verification 
 & Validation
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: 201
 6 have specific product verification and validation requirements that 
 must be fulfilled in the medical device industry. FDA is getting more 
 and more stringent about product design requirements for risk manageme
 nt and to fulfill its mandate for safety and efficacy of all medical d
 evices.\nThe design controls are now being expected from outside equip
 ment manufacturers (OEM) and all suppliers to the medical device indus
 try. This webinar will educate you on the key areas that you need to f
 ocus on to fulfill the design control and testing requirements for you
 r medical device at various phases of your product development.\nAreas
  Covered in the Session :\nProduct development process overview\nAppli
 cable design verification and validation requirements\nTesting require
 ments including the pertinent ISO Standards\nTranslation of user requi
 rements into design inputs\nRole of testing and regulatory requirement
 s\nFocusing on critical to customer and quality requirements\nDesign v
 erification and design validation activity cycles\nTraceability and ri
 sk management 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\nCompatib
 ility of the design with components and other accessories\nTest requir
 ements to fulfill acceptance criteria for final products\nHow to withs
 tand regulatory scrutiny\nHow are changes and their effects controlled
  and documented during the device life cycle?\nSummary\nWho Will Benef
 it:\nSenior management\nMiddle management\nResearch & Development\nQua
 lity Engineers and Auditors\nManufacturing Engineers\nRegulatory Affai
 rs Professionals\nQuality Assurance & Quality Control Personnel\nDevic
 e Design Team\nDevice Development Team\nDevice Manufacturing Team\nVer
 ification and/or Validation planning, execution and documentation for 
 devices.\n\nFor more information visit https://medtechiq.ning.com/even
 ts/webinar-on-test-methods-and-standards-for-design-verification-1
DTSTART;TZID=America/New_York:20160729T130000
DTEND;TZID=America/New_York:20160729T140000
CATEGORIES:webinar
LOCATION:Online
WEBSITE:https://compliancetrainings.com/SiteEngine/ProductDetailView.a
 spx?id=MD1694
URL:https://compliancetrainings.com/SiteEngine/ProductDetailView.aspx?
 id=MD1694
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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