Transcription
  • Steps. Request BUDI-DI. Start MEIC Assessment. Gather Administrative Information.
  • Do you have all Deliverables? No. Yes. Tips.
  • Draft Tech File.
  • Know Responsible Parties; Can use DHF.
  • List out missing deliverable or gaps. Inform.
  • MDR Core Team and Manager. Get Deliverable Dates.
  • Update MEIC with promise dates.
  • Pre-existing GMDN Code. Tips. No. Yes.
  • Use MCF Form (10948061DOC).
  • Takes 1-2 weeks, start in Parallel; Check RA training for form filling to avoid any delays.
  • Use NFGDC Form on RA Sharepoint. Need Material Number?. Complete Tab 4 and 10.
  • Send completed form to Anton (CM).
  • Contact SME.
  • Intro Table Details. GMDN Code & Original CE Mark Date. Codes. GSPR (need to refer in TF). Class and Rule.
  • Check GMED White Papers in J drive.
  • Contact Khaja to route it in agile .
  • Check DoC in webtop.
  • MDA & CND. No Similar Product. Similar product?.
  • Verify if same codes can be leveraged.
  • Check the Excel on EU MDR WS Teams Folder.

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