Katharina
Friedrich
Your expert for MDR-compliant and efficient clinical evaluation strategies.
Certified Professional for Medical Software (CPMS)
Active member of the European Medical Writing Association (EMWA)
100+ Clinical evaluation projects
Trusted by leading brands
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
Post-market clinical follow-up (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:
Literature reviews
User surveys
PMCF investigations
Device registries
Workshops
Efficient documentation starts with a clear structure and well-designed templates. My interactive workshops help your team streamline regulatory writing processes and ensure consistency across all documents. Together, we develop practical solutions tailored to your organization’s needs:
Optimizing templates for Clinical Evaluation and PMCF documents
Aligning documentation structure with MDR and MDCG guidance
Strengthening internal review and approval processes
Building regulatory writing skills and best practices
I am a medical doctor and medical writer by training and a MedTech enthusiast by nature.
From surgeon to regulatory strategist
My background as an orthopedic and trauma surgeon gives me the clinical perspective that makes regulatory documentation credible and reviewer-friendly. Today, I help medical device manufacturers build strong Clinical Evaluation and PMCF processes.
Clinical Evaluation projects
Clients – from Start-ups to global MedTech leaders
Workshops for medical writers
How we work together
A clear, structured process — from understanding your needs to delivering compliant, streamlined documentation. Whether you need support with Clinical Evaluation, PMCF, or team workshops, our collaboration follows the same proven steps.
Assess &
define
We start by analyzing your current documentation, templates, and regulatory strategy. Together, we identify key gaps, challenges, and opportunities for improvement.
Develop & implement
Based on our assessment, I help you define the most effective approach — from building a robust Clinical Evaluation or PMCF strategy to refining templates and internal processes.
Strengthen &
grow
Through hands-on guidance, workshops, and practical tools, your team gains the confidence and structure to maintain high-quality documentation and stay compliant in the long term.
Schedule a free session to see how we can address your regulatory challenges together.
Client Voices
We are very happy and satisfied with our collaboration with Katharina. We appreciate her expertise in the field and the excellent quality of the work delivered, as well as her flexibility and the smooth and friendly working relationship. Katharina has always kept to the agreed timelines for the various projects. Katharina has supported us in writing of Clinical Study Reports as well as other Clinical Evaluation related activities. Her writing is clear, well organised and straight to the point. We highly recommend her to support you for any medical writing type of activities.
I enjoy working with Katharina on our critical projects related to clinical evaluation writing, infographics and clinical study documentation. She consistently exceeded my expectations. Timeliness: She keeps our agreed-upon timelines. Her commitment to project deadlines ensured smooth progress and successful outcomes. Communication Skills: She is an excellent communicator. Whether it’s explaining complex medical concepts or collaborating with cross-functional teams, She ensures clarity and effective communication.Writing Proficiency: She possesses exceptional writing skills. Her ability to convey intricate scientific information in a reader-friendly manner is commendable. I wholeheartedly recommend Katharina for any medical device clinical writing or documentation needs. She is an asset to our team and contributes to the success of your projects.
We found the Medical Writing workshop very helpful and were able to benefit from the important take home messages and the tips and tricks. Thanks to the many text examples, we were able to apply what we had learned in the workshop straight away. In the 1:1 coaching, we were able to implement the content from the workshop directly and had even closer support from Katharina. Katharina was very well prepared and responded to our individual needs. All in all, an extremely successful and helpful training course.
I have had the pleasure of partnering with Katharina as an external medical writing consultant, and I can say without reservation that her expertise and professionalism have been invaluable to our team. Katharina has supported a wide range of critical activities, including authoring our annual Clinical Evaluation Reports, developing and writing our Post‑Market Surveillance (PMS) Plan and Report, and overseeing that all PMS activities are executed precisely as planned and agreed. In addition to her exceptional writing skills, Katharina has delivered multiple high‑impact training sessions on Clinical Evaluation, PMS, and Post‑Market Clinical Follow‑up (PMCF), equipping our team with both the theoretical foundations and the practical tools needed to excel. She consistently produces top‑quality documentation as well as always on time. Katharina’s ability to work independently is matched only by her commitment to alignment and collaboration. Knowledgeable, reliable, and a true pleasure to work with, Katharina Friedrich comes with my highest recommendation. Any organization fortunate enough to engage her services will be gaining a dedicated partner who elevates both process and documentation.
Insights on Regulatory Writing and Medical Device Compliance
Practical perspectives, lessons learned, and tips from my work with MedTech companies of all sizes.
Is your medical device still aligned with the State-of-the-Art?
Why do Notified Bodies keep seeing the same issues in Clinical Evaluations?
Real projects, real results
See how I've helped medical device manufacturers build robuts Clinical Evaluation and PMCF processes and navigate MDR compliance. From startups launching their first device to established companies transitioning to MDR — these projects show what works in practice.
Supporting a Start-up on the journey to CE marking
From the first State-of-the-Art research to the Clinical Development plan and the first Clinical Evaluation Report to CE-marking. Learn how I support projects from product development to the post-market phase.
Interim regulatory support for a global manufacturer
Hiring qualified regulatory professionals takes time. I can support your team until you find the right fit and help with the onboarding process.
Streamlining Clinical Evaluation processes across multiple devices
Changing processes in large companies takes time and effort. I can provide valuable input as an external reviewer and identify solutions that can easily be integrated.
