• Gather Generic Information. BUDI-DI. Intro Table Details . Complete MEIC Assessment.
  • Does GMDN Exist? Yes. No. Tips.
  • Use the NFGDC Form on RA Sharepoint.
  • Use MCF Form (10948061DOC).
  • Takes about 1-2 weeks so start in Parallel. Check RA Training for Form Filling instruction to avoid any delays. Needs Material Number and other details.
  • Send the completed form to Anton (CM).
  • Contact SME.
  • Codes & Classification. GMDN Code & Original CE Mark Date. MDA & CND Code. Class & Rule.
  • Check the DoC in webtop.
  • Check the EU MDR Workstream Teams Files.
  • Check the GMED White Papers in J Drive.
  • MEIC Excel available on EU MDR Workstream Teams. Start this prior to drafting Tech File. Pending Items/Deliverables. GSPR. Tips. ZYX.
  • Gap Assessment helps in ensuring deliverable completeness.
  • Contact SME.
  • Contact Khaja to route it in agile.
  • Use DHF for assessment.
  • Done.

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