As part of MedConf 2025, which took place in Munich from May 6 to 8, our fellows Alexander Feulner and Bernhard Sechser, together with partners from the VDI working group “Medical SPICE,” conducted several intensive coaching sessions. The aim of the coaching sessions was to familiarize participants with the new Medical SPICE model based on VDI 5702 Part 1. The focus was on the central aspects of software development in medical technology development.
Practical knowledge of standards and processes
The intensive coaching sessions not only covered theoretical basics, but also practical methods. Participants gained insights into how Medical SPICE can specifically help to integrate the requirements of the relevant standards – such as IEC 60601-1, IEC 62304, IEC 62366-1, ISO 14971, IEC 82304-1, and IEC 81001-5-1 – into development processes.
Interactive teaching for greater process maturity
For example, the coaching provided by Alexander Feulner and Tim Jones (exida) focused on structuring architecture and design as process areas. Through interactive exercises, practical examples, and joint discussions, participants were able to learn methods for achieving a higher level of maturity in their processes – a decisive advantage for successful audits and assessments, as Bernhard Sechser and Filipa Campos-Viola (FSQ) explained in another coaching session.
Target group: Experts from development, QM, and regulatory affairs
The intensive coaching sessions were aimed at developers, quality managers, and specialists and managers from the field of regulatory affairs who wanted to deepen their knowledge of Medical SPICE and test its implementation in practice.
We would like to thank all participants for their great interest and Filipa Campos-Viola (FSQ), Matthias Größler (FSQ), Tim Jones (exida), and Sebastian Dengler (iSyst) for their successful cooperation.
