iBoske | Lets Start Drafting Tech File

Nish K

Steps. Start MEIC Assessment. Request BUDI-DI. Gather Administrative Information.
Do you have all Deliverables? Yes. No. 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. Yes. No. Tips.
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. Complete Tab 4 and 10. Need Material Number?.
Send completed form to Anton (CM).
Contact SME.
Intro Table Details. Codes. Class and Rule. GSPR (need to refer in TF). GMDN Code & Original CE Mark Date.
Check GMED White Papers in J drive.
Contact Khaja to route it in agile .
Check DoC in webtop.
MDA & CND. Similar product?. No Similar Product.
Verify if same codes can be leveraged.
Check the Excel on EU MDR WS Teams Folder.