About Dr. Marc Harms
How I Work
When you hire MH-Analytics, you get me — a senior scientist with 18+ years of experience — at every stage. I don't hand off work to juniors and I don't subcontract. That means you get consistent quality and direct access to the person who actually does the work. It also means I'm selective about projects. I take on work where my expertise makes a real difference, not everything that comes through the door.
Why This Range
My work spans systematic reviews, meta-analysis, ISO 14155 clinical investigations, post-market surveillance, and sales enablement. That range is unusual — and deliberate. Clinical evidence only creates value when it connects to regulatory approval, post-market compliance, and commercial success. Most consultancies split these across different departments. I keep them in one head.
Background
Ph.D. in Natural Science (Chemistry & Materials Science). My doctoral research in biomaterials — studying how biological systems build mineralized structures — led directly into medical device research, where the same material-science fundamentals underpin implant design, biocompatibility, and clinical performance.
18+ years in clinical research and regulatory affairs for medical devices. Published in peer-reviewed journals. Biostatistics certification. Based in Moers, Germany. I work with medical device companies across Europe — from study design and protocol writing through clinical evaluation, post-market strategy, and evidence translation for the field.
Credentials
- Ph.D. in Natural Science (Chemistry & Materials Science)
- 18+ years in clinical research and regulatory affairs for medical devices
- Published in peer-reviewed journals (JSES, Journal of Pediatric Surgery, Angewandte Chemie)
- Biostatistics certification (2022–2023)
- Statistical analysis in R / RStudio
- Core methodologies: systematic reviews, meta-analysis, clinical study design
- Regulatory frameworks: ISO 14155, EU-MDR, IVDR, 21 CFR 812, ICH E6(R2)/GCP
- Direct expert access — no junior team, no subcontracting
Industries & Device Types
I work with medical device companies across a range of therapeutic areas and device categories:
Orthopedics & Spine
Implants, joint reconstruction, soft tissue repair
Surgical Devices
Instruments, energy-based devices, visualization systems
Cardiovascular
Implantable devices, vascular access, monitoring
Diagnostics & IVD
In-vitro diagnostics, imaging, point-of-care
Wound Care & Biomaterials
Advanced wound management, tissue engineering
Digital Health & SaMD
Software as medical device, clinical decision support
Interested in working together?