Medical Writing & Evidence Intelligence for Medical Devices
Clinical evidence generation for medical devices combining rigorous scientific methodology, regulatory expertise, and efficient delivery.
Our Services
Comprehensive solutions for clinical research and medical device development
Medical Writing
High-quality clinical study documents combining rapid delivery with clinical precision. Includes Clinical Investigational Plans (ISO 14155), regulatory documents (CEP/CER per EU-MDR, PMCF plans), survey protocols, reports, and data analysis.
- Efficient delivery without compromising quality
- Expert scientific methodology and clinical accuracy
- ISO 14155 & EU-MDR compliant
Evidence Synthesis
Comprehensive systematic reviews and meta-analyses that identify evidence gaps, support regulatory submissions, and inform strategic decisions. AI-accelerated literature screening combined with rigorous scientific methodology.
- Systematic literature reviews
- Quantitative meta-analysis
- AI-accelerated evidence screening
Clinical Selling Intelligence
Transform complex clinical evidence into powerful sales advantages. Product and indication-specific intelligence that empowers your sales force with evidence-based arguments and clinical confidence.
- Answer key clinical questions per product
- Plain-language evidence translation
- Sales force training & enablement
Why MH-Analytics?
Combining deep clinical expertise with rigorous scientific methodology
Expertise & Quality
Ph.D. scientist with proven systematic review and meta-analysis expertise. Published track record in both clinical and basic science.
18+ years of experience in clinical research, regulatory affairs, and materials science. Deep domain expertise in medical devices.
Regulatory ready: All documentation is ISO 14155 and EU-MDR compliant.
Value & Focus
Commercial focus: Bridge science and sales success. Translate complex evidence into competitive advantages that drive revenue growth.
No agency overhead: Direct expert access means competitive pricing without sacrificing quality. Get senior-level expertise at every stage.
Efficient delivery: Streamlined processes and deep expertise ensure faster turnaround while maintaining the highest quality standards.
About Dr. Marc Harms
Experience & Expertise
Dr. Marc Harms brings 18+ years of experience in clinical research & regulatory affairs. Deep domain expertise in medical devices. With a Ph.D. in natural science and strong publication record, I provide medical device companies with evidence-based consultancy grounded in rigorous scientific methodology and deep regulatory knowledge.
Methodological Excellence
Combining 18+ years of clinical expertise with rigorous scientific methodology to deliver comprehensive insights without compromising quality. My interdisciplinary background—from systematic reviews and meta-analysis to ISO 14155-compliant clinical investigations—enables me to bridge technical innovation with clinical evidence generation through efficient, streamlined processes.
From Evidence to Commercial Success
Beyond traditional consulting, I specialize in translating complex clinical evidence into actionable commercial advantages. Through evidence synthesis, meta-analysis, and plain-language translation, I empower your sales teams with the clinical confidence and evidence-based arguments needed to drive revenue. Whether you need regulatory documentation, strategic research planning, or sales enablement, you receive guidance that is scientifically robust, regulatory-ready, and commercially focused.
Key Qualifications
- Ph.D. in Natural Science
- 18+ Years Experience
- ISO 14155 Expertise
- EU-MDR Compliance
- Statistical Analysis (R)
- Medical Device Focus