About
Navigating the EU Medical Device Regulation (MDR) requires a rigorous and systematic approach to literature searches, ensuring compliance in clinical evaluations, post-market surveillance (PMS), and post-market clinical follow-up (PMCF). However, conducting a comprehensive and efficient search can be complex, from selecting the right databases to structuring queries effectively.

Join Dr. med. Katharina Friedrich to learn a step-by-step approach to building a robust literature search strategy tailored for MDR compliance. We will cover:
• Key considerations for literature searches in clinical evaluations, PMS, and PMCF
• Developing a comprehensive search strategy, including scoping searches and the PICO framework
• Selecting the most relevant databases for regulatory submissions
• Practical tips for organizing search results and streamlining documentation
• A hands-on use case demonstrating tailored searches for adverse events, medical device brand names, and specific clinical outcomes

Whether you are new to MDR compliance or looking to refine your search strategy, this webinar will provide actionable insights to enhance your regulatory workflows.
When
Wednesday, April 9, 2025 · 10:00 a.m. Eastern Time (US & Canada) (GMT -4:00)
Presenter
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Dr. med. Katharina Friedrich
Regulatory and Medical Writing Consultant
Katharina Friedrich studied human medicine and wrote her thesis in neurophysiology at the RWTH Aachen University in Germany. After three years of working as an orthopedic and trauma surgeon, she decided to turn her passion for writing and science into her profession. In her last position, she prepared MDR compliant documents for class I to class III devices as a Medical Writer for an international medical device manufacturer. She contributed as a speaker for EMWA webinars and led several workshops for the European Medical Writing Association.
In 2021, she founded her own consulting company and supports various medical device companies with clinical evaluations and PMCF strategies.
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