Built with practitioners
Developed in collaboration with Basysdata GmbH (Switzerland)
– a HealthIT company focused on medical informatics.
Jointly designed since Q4 2025, in pilot operation since March 2026,
going live on-premise in May 2026.
Reference customer · HealthIT · named with permission
What RegMon solves for you
- Daily, not sporadic. Changes on relevant regulatory sources are detected automatically – not when someone happens to have time to look.
- Audit evidence on demand. Every detected change is historised, archived and verifiably logged – no more folders full of screenshots.
- On-premise, no data leaves the house. Runs in your infrastructure. No SaaS dependency, no customer data leaves your environment.
- Signal, not noise. No newsletter jungle. Structured events (new / changed / removed) plus a daily report.
G-BA
KBV (incl. IT-Update index)
Gematik
IQTIG
BVITG
DGP Pathology
oBDS XML
Extensible
Who this is built for
- MedTech software vendors (10–200 employees) with MDR/ISO obligations but without a dedicated regulatory-engineering team.
- Management and compliance leads who need to know that regulatory changes are caught reliably, not by chance.
- Companies under audit pressure that must document, traceably, when what was seen.
During and after DMEA
At the Basysdata booth
Visit the Basysdata booth and ask about RegMon. For an in-depth initial conversation we are happy to schedule a separate meeting – a short email is enough.
Direct contact
Email: contact@rh-advisory.de
Phone: +49 170 8031194
Location: DE / EU · remote-first, on-premise setup at your site.
Note: this page is deliberately lean. We discuss terms and scope in person – tailored to your source and process landscape.