Webinar · Practical insight for IVD manufacturers
Automate technical documentation and introduce AI under control
How established IVD manufacturers make their grown technical documentation automatable and roll out validated software without stopping operations. Together with Confideck, with a live look at the platform, held in German.
- November 4, 2026
- Wednesday, 10:30 to 12:00 CET, on Zoom
- 90 minutes
- Online, free of charge, in German
Registration
We register you, and you will receive access to the Zoom webinar on November 4, 2026. To run the session we pass your name and email address to Confideck as co-host.
What can you expect?
Four topics in 90 minutes, two of them with a short live look at the software, and time for your questions. Two angles on the same job: the consultancy that steers documentation projects through day-to-day operations, and the platform where the documentation finally takes shape.
Why now
With product families, variants, performance documentation and continuous changes, the effort for authoring, maintenance and review grows faster than the team.
Making existing documentation automatable
Word, Excel and PDF remain part of daily work while product and regulatory information sits across DMS, eQMS, ERP and PLM. How to turn that inventory into an automatable source instead of starting from zero. With a short live look at the software.
A planned and validated rollout
A documentation project runs alongside the day job, not instead of it. Which steps in which order, what validation actually asks for, and where these projects tend to stall in practice.
Using AI under control
Where AI carries weight in technical documentation today, where it does not, and which controls keep the result defensible in an audit. With a short live look at the software.
Who is speaking?
Diana Hohage
Principal Consultant, Entourage
- 30 years in life sciences, more than 15 of them in medical technology
- Advises medical device and IVD manufacturers on regulatory strategy, technical documentation and risk management under MDR, IVDR and ISO 13485
- Lead Auditor for ISO 13485 and MDSAP
Lukas Poterpin
Managing Partner, Regulatory Affairs, Confideck
- Co-initiator of Confideck, a Vienna-based platform for automated technical documentation
- Leads regulatory affairs at Confideck for IVD, medical device and pharma manufacturers
Frequently asked questions
Prefer to talk directly? +49 89 4161170-0 · info@theentourage.de
Image notice: The illustrative and header images were generated using AI and do not depict real people, places, or events. The portrait photographs show real people.