Mark M.

I’m Dr. Mark Matus (MD), a physician and PhD researcher specializing in medical research, FDA/regulatory compliance, and clinical documentation for healthtech and AI-driven products. I help founders, medtech companies, supplement brands, and digital health startups turn complex medical and regulatory requirements into clear, evidence-based, audit-ready documentation. My approach blends clinical insight, scientific research, and regulatory accuracy into writing that is precise, structured, and professionally formatted for investors, stakeholders, and compliance teams. ⸻ 🔹 What I Do 1. Medical & Scientific Research • Literature reviews & scientific summaries • Evidence-based analysis for clinical or commercial use • White papers, research briefs & publication support • Competitive analysis & product research for supplements/medtech 2. FDA & Regulatory Compliance • Label & claims review (21 CFR, FDA/FTC) • Class I/II medical device documentation • QMS files: SOPs, Risk Management, Quality Manuals (ISO 13485) • SaMD/AI compliance guidance & intended use mapping • HIPAA documentation for telehealth platforms 3. AI/HealthTech Clinical Documentation • Clinical workflow design • Data safety & risk assessment • Medical content for LLM/AI tools • Technical writing for healthtech products • Evidence-based product positioning for investors ⸻ 🔹 Why Clients Hire Me ✔ Blends clinical, scientific & regulatory expertise ✔ Produces clean, structured, audit-ready documentation ✔ Fast communication & high reliability ✔ Helps founders understand the exact requirements ✔ Brings a unique combination: MD + Research + Regulatory ⸻ If you need medically accurate, compliant, and professional documentation that enhances credibility, reduces risk, and strengthens your product or research, I can help. Send me your goals and current status—I’ll tell you the exact steps and timeline needed.