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- Beratung & Coaching
I am a medical doctor and medical writer by training and a MedTech enthusiast by nature.
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 Clinical Development and Evaluation Plans, State of the Art Evaluation, and the Clinical Evaluation Report.
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!
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.