Utsavkumar K.

I am a Freelance Regulatory & Medical Writer (Medical Devices) supporting medical device companies with clear, structured, and compliant clinical and regulatory documentation for EU MDR and FDA requirements. I hold a Master’s degree in Regulatory Affairs and have hands-on training in medical writing, which allows me to assist clients with scientifically accurate and well-organized documentation. I focus on understanding regulatory guidelines carefully and delivering high-quality work that meets compliance expectations. I work best with startups, small manufacturers, consultants, and regulatory teams who need reliable documentation support without the cost of large consulting firms. 🔹 Services I Provide Regulatory & Clinical Documentation (Medical Devices): Clinical Evaluation Reports (CER – EU MDR) Literature Review (PubMed search + PRISMA summary) Clinical Study Reports (CSR – ICH E3 format) Post-Market Surveillance (PMS) Reports PMCF Evaluation Reports 510(k) supporting documents (sections only) IFU / Labeling review Technical file documentation support SOP creation for regulatory processes Medical Writing: CSR writing & editing Protocol writing (clinical / pre-clinical – basic to intermediate) Manuscripts & white papers Regulatory summary documents Scientific writing and evidence synthesis 🔹 How I Work Follow EU MDR, MEDDEV 2.7/1 Rev.4, MDCG guidance, ICH E3, ISO 13485, ISO 14971, and FDA 510(k) fundamentals Use structured literature searches (PubMed, Google Scholar) Write clear, well-formatted, and audit-ready documents Communicate openly and deliver on agreed timelines Continuously improve through feedback and regulatory updates I am transparent about my experience level and always focus on delivering accurate, guideline-based, and high-quality work. If needed, I am comfortable working under senior regulatory professionals or supporting existing regulatory teams. 🔹 Why Work With Me Strong academic foundation in Regulatory Affairs Trained in medical and regulatory writing Detail-oriented and guideline-focused Affordable pricing for startups and small companies Clear communication and responsive support Open to long-term and repeat work 🔹 Ideal Projects ✔ CER / literature review support ✔ CSR drafting or editing ✔ PMS / PMCF documentation ✔ 510(k) supporting sections ✔ Technical file writing assistance ✔ Regulatory documentation clean-up or formatting If you are looking for a dedicated regulatory & medical writing freelancer who values quality, compliance, and continuous improvement, I would be happy to support your project. 📩 Feel free to message me to discuss your requirements.