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:69862
DTSTAMP:20260412T081056Z
SUMMARY:Webinar on Test Methods and Standards for Design Verification 
 & Validation
DESCRIPTION:Description : Design Control is an integral part of any qu
 ality system in regulated industries. FDA Quality System regulation, Q
 uality System Inspection Techniques (QSR and QSIT) and ISO 13485: 2016
  have specific product verification and validation requirements that m
 ust be fulfilled in the medical device industry. FDA is getting more a
 nd more stringent about product design requirements for risk managemen
 t and to fulfill its mandate for safety and efficacy of all medical de
 vices. The design controls are now being expected from outside equipme
 nt manufacturers (OEM) and all suppliers to the medical device industr
 y. This webinar will educate you on the key areas that you need to foc
 us on to fulfill the design control and testing requirements for your 
 medical device at various phases of your product development. Areas Co
 vered in the Session : Product development process overview Applicable
  design verification and validation requirements Testing requirements 
 including the pertinent ISO Standards Translation of user requirements
  into design inputs Role of testing and regulatory requirements Focusi
 ng on critical to customer and quality requirements Design verificatio
 n and design validation activity cycles Traceability and risk manageme
 nt at all stages Design outputs and documentation in DMR (Device Maste
 r Records) and DHR (Device History Records) Proof for how design outpu
 ts meet functional and operational requirements Compatibility of the d
 esign with components and other accessories Test requirements to fulfi
 ll acceptance criteria for final products How to withstand regulatory 
 scrutiny How are changes and their effects controlled and documented d
 uring the device life cycle? Summary Who Will Benefit: Senior manageme
 nt Middle management Research & Development Quality Engineers and Audi
 tors Manufacturing Engineers Regulatory Affairs Professionals Quality 
 Assurance & Quality Control Personnel Device Design Team Device Develo
 pment Team Device Manufacturing Team Verification and/or Validation pl
 anning, execution and documentation for devices. Startup Company Leade
 rs\n\nFor more information visit https://medtechiq.ning.com/events/web
 inar-on-test-methods-and-standards-for-design-verification
DTSTART;TZID=America/New_York:20160629T130000
DTEND;TZID=America/New_York:20160629T140000
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
END:VEVENT
END:VCALENDAR