Presentation materials: Regulatory Update: Sustainability, DiGA, Safety vs. Security, UDI, and EUDAMED from May 21, 2025

On May 21, 2025, we held our online forum on the topics of sustainability, DiGA, safety vs. security, UDI, and EUDAMED.

Around 70 interested parties attended the expert updates, giving them a quick, up-to-date overview of developments and requirements.

Here you can download all presentation materials:

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  Sustainability in Medtech
  
  
  Laura Daviña König, Human.technology Styria
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  Digital health applications (DiGA) – current legal developments
  
  
  Dr. Gisela Ernst: Universität Wien
  Dr. Ingrid Jez: Lawyer specializing in medical and health law (including data protection law)
• 
  
  Safety vs. Security – a risk assessment
  
  
  Volker Sudmann, Niederlassungsleiter austria, mdc medical device certification
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  Update on UDI and EUDAMED
  
  Poppy Abeto Kiesse, Business Development Manager Healthcare, GS1 Austria

We would like to thank all speakers and the organization team of Human.technology Styria, LISAvienna, Standortagentur Tirol, ecoplus NÖ, Medizintechnik-Cluster OÖ and Innovation Salzburg – without this great cooperation this free offer could not be realized!

Event recommendations from Life Science Cluster & en.co.tec:

• Webinar series: Sustainable future for life science @ online
• Webinar “Reuse, Repair, Refurbish” 26.05.2025 @ online
• Life Sciences Partnering Tirol 04.-05.06.2025 @ Innsbruck
• en.co.tec Spring Academy: Digital Health-AI-Cybersecurity on 11.06.2025 @ online
• SPECIAL online forum: Health Tech in cooperation with FH Technikum Wien on 12.06.2025 @ online
• MTC: Medical.Materials am 16.06.2025 @ Linz
• LISAvienna Regulatory Affairs Conference on 15.10.2025 @ Vienna – Registration starts end of May!

Further information on the topics of QM and medical software:

• Practical guide for manufacturers of medical device software
• Quality management support & internal audits according to ISO 13485

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