About
Dr. Marc Harms
Independent clinical research consultant based in Germany. PhD in Natural Science, 18+ years in medical device clinical research and regulatory affairs — one person, no handoffs.
How This Works
Hiring MH-Analytics means working directly with a senior scientist with 18+ years of experience, at every stage. There are no handoffs to juniors and no subcontracting — just consistent quality and direct access to the person who actually does the work, with selectivity about projects: only work where the expertise makes a real difference, not everything that comes through the door.
Why This Range
The 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; here they stay in one head.
Background
PhD in Natural Science (Chemistry & Materials Science). 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. Working 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
- —PhD 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
Working 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?