How To Best Document The Clinical Evaluation Report (CER) For The CE Mark

  • Instructor : John E. Lincoln
  • Level : Intermediate
  • Study time : 97 minutes
  • Course ID: TF3653
  • Included in Subscription Pack
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ABOUT THE COURSE

Is your CER structured to satisfy EU MDR reviewers?
Struggling to define state-of-the-art in practical terms?
Not sure which clinical data really matters?


This course will guide you in building a strong, regulator-ready CER with clarity on clinical evidence, structure, and safety validation.


WHAT WILL YOU GAIN
  • Real clarity on CER components required by EU MDR
  • Confidence in citing state-of-the-art and benchmark devices
  • A smarter approach to documenting post-market data


WHY TAKE THIS COURSE
  • Turn your CER into a powerful compliance tool
  • Eliminate confusion around literature reviews and formatting
  • Stay aligned with evolving EU regulations and expectations


KEY AREAS COVERED
  • Understanding the role and purpose of the CER
  • MEDDEV 2.7/1 Rev 4 and EU MDR 2017/745 requirements
  • Preclinical and clinical data collection and analysis
  • Proper use of state-of-the-art in context
  • Types of clinical evidence and how to reference them
  • Best practices for literature search documentation

Quality training, expert insights, and answers that matter. Know your Expert

JOHN E. LINCOLN

John E. Lincoln is Principal of J. E. Lincoln and Associates LLC, a global regulatory and QA consulting firm. With over 36 years in FDA-regulated industries, including 22 years as an independent consultant, he has guided startups to Fortune 100 companies on quality systems, risk management, validation, and compliance. He's a go-to expert for EU MDR, ISO 14971, 510(k) strategy, and design control documentation. A published author, global speaker, and columnist for the Journal of Validation Technology, John's deep regulatory insight and real-world approach make him the perfect guide for this course.

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