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Welcome to the MH-Analytics Blog

Dr. Marc Harms
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Welcome to the MH-Analytics Blog

This blog is a practical resource for medical device teams who need clear, evidence-based guidance on clinical research, regulatory documentation, and strategic evidence generation. It distills 18+ years of hands-on experience into actionable insights you can apply immediately.

Who This Blog Is For

  • Medical device founders and executives preparing for EU market entry
  • Clinical and regulatory teams building ISO 14155-compliant documentation
  • Product and commercial leaders who need evidence-backed positioning
  • Consultants and partners supporting EU-MDR submissions

What You’ll Get (Practical Value, Not Theory)

Each post will deliver clear takeaways, checklists, and examples you can apply in real projects.

Core Topics

  • ISO 14155 Best Practices
    Practical guidance on clinical investigation protocols, risk-based monitoring, and documentation structure.

  • EU-MDR Evidence Strategy
    How to build a defensible clinical evidence package and avoid common submission delays.

  • Medical Writing Excellence
    How to structure protocols, CEP/CERs, PMCF plans, and reports for regulatory clarity.

  • Evidence Synthesis
    Efficient approaches to systematic reviews and meta-analyses that stand up to scrutiny.

  • Commercial Evidence Translation
    Turning data into clear, credible messages that help clinical sales teams perform.

How I Work (And Why It Matters)

I combine scientific rigor with commercial relevance. That means:

  • Evidence that is regulatory-ready, not just “nice to have”
  • Documents that are consistent, defensible, and audit-friendly
  • Insights that support both approvals and market adoption

Example Post Formats You Can Expect

  • “5 Critical Mistakes in ISO 14155 Protocols (and how to avoid them)”
  • “EU-MDR: What reviewers look for in your Clinical Evaluation Plan”
  • “How to build a literature screening process that is fast and defensible”
  • “Turning evidence into a sales narrative without over-claiming”

Suggested Next Steps for You

If you’re preparing regulatory documentation or evidence synthesis, I can help you:

  1. Clarify the clinical strategy
  2. Optimize documentation structure
  3. Strengthen evidence for submission and market use

Stay Connected

Have a topic you’d like me to cover? Want a specific checklist or template?
Feel free to reach out, and I’ll prioritize it.

Dr. Marc Harms
MH-Analytics