The objective of this workshop for start-ups is that each participating company implements an ISO 13485:2016 QMS and receive training on the procedures.
Eight workshops (2-4 hours each) are at the core of this initiative.
They are conducted by one expert and together with various Start-Ups. Prior to each workshop, the respective documents, SOPs and templates are provided in an electronic format.
The participants then study the material and prepare for the workshops (e.g. relevant questions for their specific needs / field of application).