Mona M.

🏆Upwork Expert-Vetted Badge (Top 1% performer, badge only visible to Upwork Enterprise Clients) 🔗Chief Executive Scientist & Founder @Apranik MedTech Consulting LLC 🌟Former academic with a PhD in Biomedical Engineering, and a life-long passion for research and technical or scientific writing/presentation. I bring over a decade of experience in the Medical Device industry, working with leading companies like Medtronic, Abbott, and Edwards Lifesciences in roles such as Clinical & Regulatory Affairs Scientist and Senior Strategy Manager. I have written and edited over 400 scientific manuscripts, grants (NIH & NSF), reports, and other technical works. I can help you with any scientific writing/presentation needs. 👉My services encompass a range of offerings, including: • Regulatory Submission & Compliance: FDA, Health Canada, and EU notified bodies (FDA: Q-Sub, 510(k), De Novo, PMA), Health Canada (MDEL, MDL), EU notified bodies (MDD to MDR) and responses (deficiency letters, questions) • Evidence Gap: Identification, Evidence Dissemination and Strategy • Clinical Trials: Design, Documentation, Management, Reporting (All stages, all devices or therapies) • Scientific Writing & Presentation: Journals, Conferences, Posters, Slide Decks, White Papers, Reports, Grants (NIH and NSF SBIR/STTR) 👉SKILLS & KNOWLEDGE: •Specializing in FDA (510(k), PMA), Health Canada, and EU Notified Bodies, I support regulatory pre-submissions/submissions, deficiency letter responses, design considerations, and EU MDR revisions. I am certified in EU MDR clinical evaluation submissions (CEP, CER, PMCF, SSCP) and FDA Reports (Annual Progress Report, Clinical Study Report). •My expertise lies in evidence gap identification, dissemination, and strategy, aiding in overcoming clinical, regulatory, or payers' challenges. •With a strong background in Clinical Research, I offer assistance in trial design, methodology, documentation (protocols, informed consents, contracts, case report forms, IRB/EC, statistical analysis plans, monitoring plans, safety plans, etc.), and all trial stages (feasibilities, randomized trials, and post-market observational studies) across multiple disease states. •As a well-published scientist (15+ First-author peer-reviewed manuscripts and conference papers) with 20 years of extensive experience in data analysis and visualization, I can support you with any scientific writing and presentation needs. 🤝If you need assistance navigating the complex landscape of scientific services for investigators, startups, or MedTech companies, feel free to reach out. I look forward to collaborating with you!