Monday, 13 October 2025 | 13:15 - 14:45

Workshop "Regulatory Affairs for Digital Medical Devices"

Location:Kleiner Dachboden (Upstairs)Track:Track A

This workshop, designed by en•co•tec®, is a crash course in regulatory affairs on digital medical devices for collaboration projects.

It covers the following areas:

  • Regulatory background – EU regulations for medical devices

  • Where can you find support, useful resources and websites

  • Dos and don'ts – unwritten rules

en•co•tec® is a consulting firm based in the south of Vienna, specialising in regulatory affairs and quality management for medical devices and in vitro diagnostics. With their consulting services and the en.co.tec Academy, en•co•tec® supports industry newcomers, start-ups, and leading manufacturers and suppliers in the medical device industry.

1 speaker

  • Head of Quality / PRRC / DPO / CISO; Senior Consultant & Lead Auditor; ISO/IEC Technical Expert TC62

    en.co.tec Schmid KG