Automation in the production of medical technology

What requirements does modern production place on medical technology manufacturing?
How can automation help to manufacture more economically, efficiently, and with less risk?
Can proper validation and attention to cybersecurity elevate medical technology manufacturing to a new level?
And what added value does the Manufacturing‑X initiative bring, creating trusted data ecosystems based on open standards?

We will discuss all of these questions at MedtecLIVE in a session organized by VDMA.

13:45 – Requirements for the manufacture of medical technology products, illustrated by the example of an automated stent production line
Edgar Mähringer-Kunz, Managing Director / General Manager, IMSTec GmbH

14:10 – Increasing productivity and efficiency through data spaces with Manufacturing‑X
Kerstin Zappe, Consultant SCALE‑MX, VDMA e.V. – Manufacturing‑X Forum

14:30 – Less effort, more compliance – validation of computer systems in the cloud
GAMP5 2nd edition, new technologies and AI – why validation is losing its fear factor in medical technology
Jens Fröhlich, Principal Consultant Operations – Portfolio Management MEDTEC, KUMAVISION AG

14:50 – Cybersecurity aspects in the design transfer from product development to an automated production environment for medical devices
The focus is on software integrity requirements in accordance with IEC 81001‑5‑1 and the FDA Cybersecurity Guidance, as well as traceable deployment processes safeguarded by early automated testing to prevent production risks.
Dirk Müller, Ph.D., Operations – Portfolio Management MEDTEC, StingOrg GmbH

Please note: The presentation will be held in German and translated into English in written form using AI, available to read along during the session.

Supported by VDMA HealthTech