Please download the entire zip file containing all documents needed

This repository does not only provide all material to fabricate the 3D Footplate but also offers a substantial set of documentation to speed up the Medical Device Regulation compliance process. Best way to start is as follows:

-Order the parts using 3.03.3D Footplate Bill of Materials v1.2

-Laser cut the parts indicated in 3.03.3D Footplate Bill of Materials v1.2, using folder 0302_Technical Drawings and laser settings indicated in 3.04.3D Footplate Lasercutter Settings v1.1

-3D print the parts indicated in 3.03.3D Footplate Bill of Materials v1.2, using folder 0301_3D Models

-Assembly all components using 3.04.3D Footplate Assembly manual v1.1

-Execute tests according to 6.3D Footplate preclinical validation

-Do additional tests to verify, validate or mitigate all risks indicated in 5.3D Footplate Hazard Traceability Matrix v1.1, and all criteria indicated in 3.00.3D Footplate DesDev v1.4 and in 4.01.3D Footplate GSPR checklist v1.3

-Complete documentation to comply with the Medical Device Regulation using remaining document 1.3D Footplate Device Classification v1.1

-To do this process properly consult a MDR expert and study the background material offered in the form of MSc theses, vanElst_MScThesis_UTwente, Masih_MScThesis_UTwente and Norg_MScThesis_TU Eindhoven; and scientific publications as indicated in 1.3D Footplate Device Classification v1.1

-Once all steps are in place, use 2.02.3D Footplate User manual v3.0 for proper use of the 3D Footplate and 2.02.3D Footplate Maintenance manual v1.0 to replace or tweak components