PURPOSE / OBJECTIVE
A suitable training concept for users and assessors is to be developed for this PAM. Ideally, these trainings should conform to the PAM trainings of other industries such as automotive. Hence the idea to apply the intacs concepts here as well. The aim group is developers of medical software as well as potential assessors from this or other sectors.
VDI 5702 Sheet 1, a suitable training concept for users and assessors is to be developed. https://www.vdi.de/richtlinien/details/vdi-5702-blatt-1-medizinprodukte-software-medical-spice-prozessassessmentmodell
DELIVERABLES
- Training material for "intacs® certified Expert for Medical SPICE"
MEMBERS
Dr. Filipa Campos-Viola
Tim Jones
Sebastian Dengler
Alexander Feulner
WORKING GROUP LEADER
Bernhard Sechser