Medical Writer

As a Medical Writer I provide freelance writing services to medical device companies, CROs, service providers, academic institutions and medical communication companies.

• Clinical Evaluation Plan
• Clinical Evaluation Report
• Klinische Bewertung
• Klinische Studie
• MDR 2017/745
• MEDDEV 2.7/1 Rev.4
• Medical Writing
• Regulatorische Dokumente
• Regulatory Affairs Management
• Regulatory Writing

I have a background in Biomedical Engineering and Biology from RWTH AACHEN UNIVERSITY and an additional Regulatory Affairs Certification for Medical Devices from the University of Applied Science Lübeck and the University of Lübeck.

My strengths include summarizing complex scientific data in a clear and concise manner with a high attention to detail and quality.

Area of expertise:
✅ Over 4 years experience in MDR-compliant documents (CEP, CER, PMCF Plan & Report, etc.)
✅ Over 10 years experience in medical writing, editing and proofreading
✅ Systematic literature searches (PubMed, Cochrane Library, etc.)
✅ Clinical areas: Cardiovascular, Urology, Tissue Engineering & Regenerative Medicine, Orthopedics

Key skills:
⭐️ Structured, accurate and clear content
⭐️ Attention to detail
⭐️ Ensuring high quality
⭐️ Customized services
⭐️ Easy to work with, professional and friendly communication

I provide all my services in English and German.

As a member of the European Medical Writers Association (EMWA) I regularly participate in training courses regarding regulatory topics and clinical evaluation of medical devices.