katylistic

Medical Writing and Consulting by Dr. med. Katharina Friedrich


I write regulatory documentation for medical devices and pharmaceutical companies. My background as a medical doctor allows me to deeply understand the medical conditions relevant to your product. 
Clinical Evaluation Plans and Reports, Post-market Clinical Follow-up documentation, and Summaries for Safety and Performance in compliance with the EU MDR 2017/745 are part of my daily work.
As a passionate writer, I love communicating medical and scientific data to patients or HCPs. This includes preparing website content, blog articles, or social media posts. 
  

Portfolio

Regulatory Writing

  • Clinical Evaluation Plans and Reports
  • Post-market Clinical Follow-up Plans and Reports
  • Summary of Safety and Clinical Performance
  • State of the Art evaluation
  • Systematic literature searches 
  • Clinical Investigation Plans and Reports

Medical Education

  • Patient brochures and Lay summaries
  • Website content for lay persons and healthcare professional
  • Blog articles and Social Media Content




Workshops and Training

  • Workshop leader for EMWA and LS Academy
  • Training for Medical Writers on: PMCF and SSCP for Medical Devices, Instructions for Use for Medical Devices, State of the Art Evaluation for Medical Devices
  • Online and On-Site Training

 

Mission

I provide high-quality and reliable medical writing solutions for medical device and pharmaceutical companies. My extensive knowledge in regulatory writing, medical education, and my practical experience as a doctor allow me to take a comprehensive view at your projects.