Clinical evidence problems. Solved.
I help medical device companies build clinical evidence strategies that satisfy regulators, survive audits, and support commercial success. Ph.D., 18+ years in medical devices. EU-MDR, FDA, ISO 14155.
Independent clinical research consultant based in Germany. My doctoral research in biomaterials led directly into medical device clinical evaluation — and 18 years later, I still connect the science to the regulatory strategy. One person, no handoffs.
More about meHow I Can Help
Clinical Strategy & Study Design
Protocol development, sample size estimation, systematic reviews, statistical analysis
Post-Market Clinical Roadmap
CER/CEP, PMCF, PMS strategy, evidence gap analysis, vigilance SOPs
Evidence-Based Field Communication
Evidence dossiers, training workshops, clinical question mapping
Latest Insights
Perspectives on clinical evidence, regulatory strategy, and statistical methods
December 28, 2025
Time Series Forecasting for Critical Systems: Building Reliable Predictions with ARIMAX
A practical guide to ARIMAX modeling for forecasting critical infrastructure, demonstrating how classical statistical methods deliver transparent, validated predictions—illustrated with German gas storage forecasting.
Read →December 15, 2025
Forest Plots in R with metafor: From Basic to Publication-Ready
A hands-on guide to creating forest plots in R using metafor — from simple plots to publication-ready figures with heterogeneity stats, prediction intervals, and detailed study-level annotations.
Read →December 10, 2025
Beyond the Standard Model: Multilevel and Multivariate Meta-Analysis for Complex Clinical Evidence
A practical guide to multilevel and multivariate meta-analytic models — handling dependent effect sizes, correlated outcomes, longitudinal data, and arm-based analyses in clinical research.
Read →How Engagements Work
Every engagement starts with a brief scoping call. You receive a written proposal with defined deliverables, timeline, and fixed project fee — no hourly billing surprises.
Protocol review, SAP review, CER gap analysis, literature search validation.
Typical scope: 1–3 weeks
Full CER, PMCF plan, systematic review, statistical analysis, clinical investigation plan.
Typical scope: 4–12 weeks
Post-market clinical roadmap, evidence strategy, M&A due diligence.
Typical scope: 2–6 months
You work directly with me throughout — no handoffs, no junior staff, no subcontracting.
Ready to discuss your project?
Send a brief description of your project — device type, regulatory context, and what you need. I'll respond within 48 hours with an initial assessment and a proposed next step.
Or call directly: +49 1515 79 43 500