EF Medical Writing
Professional Medical Writing Services
by
Dipl.-Biol., M.Sc. Eva Freitag
Welcome!
My name is Eva Freitag and as a passionate medical writer I provide freelance medical writing services to medical device companies, CROs, service providers, and medical communication companies.
I have a background in biomedical engineering and biology (RWTH Aachen University) and an additional Regulatory Affairs Certification for medical devices (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.
As a member of the European Medical Writers Association (EMWA) I regularly participate in trainings regarding regulatory topics and clinical evaluation of medical devices.
Depending on your demand, I provide all my services in English or German language.
Writing Services
Regulatory Writing
in accordance with the European Medical Device Regulation (MDR) 2017/745
- Clinical Evaluation Plans (CEPs)
- Clinical Evaluation Reports (CERs)
- Post-Market Clinical Follow-Up (PMCF) Plans and Reports
- Systematic literature searches
- State of the Art (SOTA) evaluations
- Summary of Safety and Clinical Performance (SSCP)
- Template preparation (CEP, CER, PMCF Plan and Report, SSCP, PSUR, Risk Management Plan and File, Usability Engineering File, etc.)
Medical Writing
regarding any topic related to medicine, biomedical engineering, biology and health
- Articles and Whitepapers
- Data analysis and infographics
- Educational materials
- Marketing materials
- Scientific publications
- Conference abstracts and presentations
- Editing and proofreading
- Website content
- Translation services (English/German)
Area of Expertise
✅ More than 4 years of experience in MDR compliant documents:
- Clinical Evaluation Plans (CEPs)
- Clinical Evaluation Reports (CERs)
- State of the Art evaluations (SOTA)
- PMCF Plans and Reports
✅ Supported over 25 clinical evaluation projects from Class I to Class III medical devices
✅ More than 10 years of experience in medical writing
✅ Systematic literature searches and reviews
✅ Clinical areas: Cardiovascular Medicine, Tissue Engineering & Regenerative Medicine, Urology, Orthopedics and more
Key Skills
- Structured, accurate and clear content
- Attention to detail
- Ensuring high quality
- Customized services
- Easy to work with
- Professional and friendly communication
- Up to date with regulatory requirements
Academic Education
Master course in Biomedical Engineering (M.Sc.)
RWTH Aachen University, Faculty of Medicine, 2007-2011
Field of study: Tissue Engineering, Artificial Organs & Implants, Medical Imaging, Image Guided Therapy
Diploma course in Biology (Dipl.-Biol.)
RWTH Aachen University, 2001-2007
Field of study: Molecular and Cell Biology, Human Biology, Microbiology, Virology
Certificates
European Medical Writers Association (EMWA) - Professional Development Programme (EPDP)
- How to write a Clinical Evaluation Report (2023)
- What Medical Writers should know about Medical Device Software (2023)
- Understanding instructions for use for medical devices and providing support in their drafting (2022)
- Writing the State for the Art of medical devices to the EU Medical Devices Regulation (2022)
University of Applied Sciences Lübeck and the University of Lübeck
Regulatory Affairs Manager, Certification Course (2019-2020)
- Legal requirements for medical devices and in-vitro diagnostic medical devices in the European Economic Area (EEA)
- Approval and registration of medical devices outside the European Economic Area (EEA)
- Regulatory requirements for medical devices in the USA
- Quality management systems for medical devices according to ISO 13485
- Risk management systems according to ISO 14971
- Usability Engineering for medical devices according to IEC 62366-1
- Clinical evaluation and clinical investigations of medical devices
- Requirements for electrical safety according to IEC 60601 and IEC 61010
- Requirements for software as a medical device according to IEC 62304
- Requirements for health software according to IEC 82304-1
- Requirements for sterilization and biocompatibility of medical devices
Do you require immediate support of a team?
I collaborate with other freelance medical writers, offering the flexibility of team bookings. This enables us to combine our skills and provide comprehensive, tailored solutions to our clients' needs - quickly and effectively!
Whether working as individuals or as a team, we are committed to providing high quality services.
Memberships
I am a member of the European Medical Writers Association (EMWA) and of the RAPS Regulatory Affairs Professionals Society Germany e.V.
