MH-ANALYTICS
Clinical Research Consultancy · Medical Writing · Process Optimization · CTMS
Independent consultancy for medical device companies. Ph.D., 18+ years in clinical research and regulatory affairs. EU-MDR, FDA, ISO 14155 — one person, no handoffs.
Clinical Research Consultancy
Evidence strategy, systematic reviews, meta-analysis, and clinical investigations that hold up to notified bodies and auditors.
Strategy & evidenceMedical Writing
CERs, PMCF plans, protocols, SAPs, and study documentation — written by the person who designed the analysis.
Documents that survive reviewProcess Optimization
SOP audits, workflow automation, and study operations that stop draining your clinical team's time.
Operations & workflowCTMS
A lightweight study management tool for Investigator-Initiated Studies — built to replace Excel lists and SharePoint folders.
Try the live demoCTMS for Investigator-Initiated Studies
Still managing IIS in Excel and SharePoint?
Most small and mid-size medtech companies track investigator-initiated studies across spreadsheets and shared folders — until something gets lost. There is a lighter way than an enterprise CTMS.
The spreadsheet reality
- IIS status scattered across spreadsheets, inboxes, and shared folders
- Missing contracts or reports found only during audit preparation
- Milestones and budgets tracked differently in every department
What the CTMS gives you
- One structured register: studies, sites, investigators, milestones
- Document completeness tracked against your SOP requirements
- EU data hosting — on secure servers in Germany
See it yourself — live demo with mock data:
Selected Engagements
Anonymized examples of recent client work — scope, deliverables, and timeline
Clinical Research SOP System
Complete clinical research SOP set — 20+ SOPs with forms and templates covering study planning, IB development, site selection, IIS governance, safety management and reporting, risk management, DSMB, data and documentation management, training, CIP, ICF, SAP, CIR, monitoring, CRO management, and regulatory submissions (FDA 510(k), EU, BfArM/EC).
Delivery: 3 months
Clinician Feedback Program
Designed the customer-feedback questionnaire for a flagship product, conducted face-to-face 1:1 clinician interviews at an EMEA advisory board summit, and delivered meeting minutes plus a full statistical analysis report — per-item Likert statistics with exact confidence intervals and a structured bias and limitations assessment.
Delivery: 1 week
Class III Pre-Market Study Package
End-to-end preparation of a Class III pre-market study: non-inferiority CIP against a historical control built from multiple systematic reviews, plus the Investigator's Brochure and the complete statistical design — sample size, endpoints, and SAP.
Delivery: Recurring
Latest Insights
Perspectives on clinical evidence, regulatory strategy, and statistical methods
April 14, 2026
ISO 14155:2026 vs. ISO 14155:2020: What Actually Changed, and What It Means for Your Studies
The fourth edition of ISO 14155 replaces the 2020 version with a technically revised standard. This post walks through the substantive changes, separates the genuinely new requirements from the clarifications, and explains what sponsors and investigators need to do about ongoing and planned medical device studies.
Read →January 10, 2026
Investigator-Initiated Studies in MedTech: The Good, the Bad, and the Ugly
Everyone loves investigator-initiated studies until they have to manage one. A walk through how IIS should work in the European medtech world, why they are genuinely valuable, where they quietly fail, and where they were never meant to succeed in the first place.
Read →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 →Ready to discuss your project?
Send a brief description of your project — device type, regulatory context, or the workflow you want to fix. I'll respond within 48 hours with an initial assessment and a proposed next step.
Or call directly: +49 1515 79 43 500