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UID:2140535:Event:62863
DTSTAMP:20260913T010713Z
SUMMARY:Webinar On - Medical Device Changes and the 510(k)
DESCRIPTION:This webinar will provide valuable guidance to regulated c
 ompanies in development and implementation of formal, defined, documen
 ted methods for analysis of product changes and when to file a new 510
 (k).  Consideration of the U.S . FDA's current K-97-1 Memo / guidance 
 document on \"510(k) Device Modifications\"  Control of medical device
  changes and a current 510(k) are big issues in recent FDA studies. Co
 mpanies are held fully responsible for deciding when a new 510(k) fili
 ng is warranted. Often this is a difficult decision process. Effective
  change control and the power of current risk management tools must be
  a major part of such an analysis. The U.S. FDA has its current K-97-1
  Memorandum (they recently pulled their proposed new draft Guidance Do
 cument, \"510(k) Device Modifications: Deciding When to Submit a 510(k
 ) for a Change to an Existing Device\"). K97-1 provides a tool to assi
 st in device and new 510(k) / change analysis. The addition of such si
 mple tools will assist companies in implementing formal, documented, r
 epeatable methods with defensible rationale for their decisions on whe
 n changes trigger the need for a new 510(k) submission.  The K97-1 ana
 lysis is the preferable tool to work with a company's change control s
 ystem to document the need to file, or the rationale for not submittin
 g a 510(k). It is recommended as the preferred method for documentatio
 n of each change in a device during its lifecycle.  Provides for a St
 ep-by-step analysis: Manufacturing, Labeling, Tech / Performance, and/
 or Materials Changes. Consideration of which of the three major 510(k)
  formats should be used: Traditional, Special or Abbreviated.\n \nAre
 as Covered in the Session :\nThis webinar will provide valuable assist
 ance to all regulated companies performing and documenting meaningful,
  results driven 510(k) / change analysis activities, based on the FDA'
 s current Guidance on 510(k) Device Modifications. This session will c
 over:\n\nDeciding When to Submit a 510(k) for a Change to an Existing 
 Device, K97-1\nHow to provide tools to document such decisions\nIt wil
 l discuss how companies can best document their decisions -- whether o
 r not a new 510(k) filing is warranted\nHow to structure a decision ma
 trix to document change decisions\nHow to evaluate changes that could 
 trigger the \"Tipping Point\"\nWho makes the decisions and how to defe
 nd them\nHow to implement formal methods with documented, and defensib
 le rationale\nPreparing for further 510(k) changes in the future\n\n 
 \nWho Will Benefit:\nThis webinar is a must for companies in the Medic
 al Device and combination products fields. The employees who will bene
 fit include:\n\nResearch & Development\nEngineering Staff\nQuality Ass
 urance\nRegulatory Affairs\nLean & Six Sigma staff\nNew Product Develo
 pment\nMarketing\nMid-level and Senior Management\nProject Leaders\nCo
 nsultants\n\nAddress:5939 Candlebrook Ct, Mississauga, ON L5V 2V5, Can
 ada Customer Support : 416-915-4458support@compliancetrainings.comhttp
 s://www.compliancetrainings.com/SiteEngine/ProductDetailView.aspx?id=M
 D1025\n\nFor more information visit https://medtechiq.ning.com/events/
 webinar-on-medical-device-changes-and-the-510-k
DTSTART;TZID=America/New_York:20140212T120000
DTEND;TZID=America/New_York:20140212T130000
CATEGORIES:online, training
LOCATION:Online
WEBSITE:https://www.compliancetrainings.com
URL:https://www.compliancetrainings.com
CONTACT:416-915-4458
ORGANIZER;CN=compliancetrainings:https://medtechiq.ning.com/profile/co
 mpliancetrainings
ATTACH;FMTTYPE="image/jpeg":http://storage.ning.com/topology/rest/1.0/
 file/get/2562011031?profile=original
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN=complianc
 etrainings:https://medtechiq.ning.com/profile/compliancetrainings
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