ADVISORY
Strategy · Cybersecurity · Compliance
38th European Congress of Pathology · Stockholm · 12–16 September 2026
We are not exhibiting. Our reference customer Basysdata is attending – ask them about RegMon, or write to us directly.

Regulatory monitoring
that holds up in an audit.

RegMon is an on-premise system for daily change detection across the regulatory sources that govern pathology software and diagnostics in the German-speaking market: DGP, the oBDS XML schema, G-BA, KBV, Gematik. Traceable, audit-ready, no SaaS dependency.

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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, running on-premise in production since June 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.
DGP Pathology oBDS XML schema G-BA KBV (incl. IT-Update index) KBV (12 web sections) Gematik Further sources on request

Who this is built for

  • Digital-pathology and LIS vendors selling into Germany, Austria or Switzerland. Market access here means tracking G-BA, KBV, Gematik and the oBDS XML schema continuously – in German, from sources that rarely announce their changes.
  • Pathology institutes and laboratories under accreditation pressure that must document, traceably, when a regulatory change was seen and what followed from it.
  • 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.

Meeting us around ECP 2026

At the congress

We are not exhibiting this year. Colleagues from Basysdata are attending and are happy to talk about how they use RegMon day to day. For a technical conversation, write to us – we will arrange a call during or after the congress.

Direct contact

Email: contact@rh-advisory.de
Phone: +49 170 8031194
Location: DE / EU · remote-first, on-premise setup at your site.

Send an email enquiry Technical details

Note: this page is deliberately lean. We discuss terms and scope in person – tailored to your source and process landscape. A live demonstration of the running system can be arranged remotely.