Medical Writing and Consulting by 

Dr. med. Katharina Friedrich, MD


Your expert for MDR-compliant and efficient clinical evaluation strategies


I am a medical doctor and medical writer by training and a MedTech enthusiast by nature. 

 

Supported + 50 clinical evaluation projects

Worked with + 20 clients: from Start-ups to one of the biggest players in MedTech 

Presented + 10 workshops for medical writers

Certified Professional for Medical Software (CPMS)

Active member of the European Medical Writing Association (EMWA) 



Regulatory Writing Portfolio

Clinical evaluation

The clinical evaluation is the heart of every technical documentation. Finding the right strategy is crucial for your MDR certificate. I can support you with establishing the:

  • Clinical Development Plan
  • Clinical Evaluation Plan
  • State of the Art Evaluation
  • Clinical Evaluation Report

PMCF

The requirements for post-market clinical follow-up have been reinforced with the EU MDR 2017/745. Any gaps identified in your Clinical Evaluation Report should be closed with the right PMCF activity. Let's find the right solution for your product:

  • PMCF Plan
  • PMCF Evaluation Report


SSCP

The Summary of Safety and Clinical Performance is required for all class III and implantable devices. It consists of a section for healthcare professionals and one for patients, if applicable. As the SSCP is made available to the public, I am happy to support you in writing this document in the most efficient way. 

Clients


Permission to display company logos was provided by the manufacturer.  

Client Voices

"Katharina is an excellent medical writer. She is good at focusing on what we need and require. Her experience, her background and her professionalism give added value to the work done with her support. I am so happy to have found her and to have her as a consultant."
 Senior Clinical Affairs Manager, Start-up Company, Italy 

"Katharina has been a great asset to our team and instrumental in our MDR submission.  She prepared high quality clinical documents on time and supported us with strategic decisions. Katharina is a fantastic medical writer, well-tuned into the latest regulatory updates, always responsive and willing to help. Combined with her strong clinical expertise, she is a valuable contributor to any team. It is a pleasure working with Katharina and would I recommend her wholeheartedly!"
 Clinical Evaluator and Project Manager, International MedTech Company, Sweden 

"Katharina is a passionate medical writer, dedicating her time and deep thought to the projects under her management. She actively ensures to dive into details delivering precise results and documentation. She is always able to satisfy clients needs, clearly expressing passion and professionality throughout the engagement. Working with her is a pleasure."
 Regulatory Clinical Affairs Manager, International MedTech Company, Switzerland