iBoske | Lets Start Drafting Tech File

Nish K

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.