Fundamentals of Biostatistics in Clinical Studies of Medical Devices - Learn to Convince with Statistical Significance
This course provides a clear and practice oriented introduction to the fundamentals of biostatistics in clinical studies for medical devices. Participants learn how statistical principles support the demonstration of safety and performance in accordance with Regulation (EU) 2017/745, ISO 14155, and MDCG 2024 3. The training covers the formulation of hypotheses, sample size calculation, and the selection of appropriate statistical methods. Through practical examples, learners gain the skills needed to analyze clinical data correctly and present statistically sound results in clinical investigation reports.
Course Outline
- Regulatory framework for statistical requirements in clinical studies
- Fundamentals of study design and endpoint definition
- Core statistical concepts and terminology
- Sample size calculation and avoidance of bias
- Hypothesis testing and selection of statistical methods
- Analysis and interpretation of clinical data
- Practical examples aligned with ISO 14155 and MDR requirements
Course Tutor
Silvia Georges, PhD, is Manager, Medical Device Consulting, Clinical Affairs & Biological Safety at NSF. She has worked at NSF for more than seven years and has over a decade of experience across regulatory affairs, basic animal research, the pharmaceutical sector, and the medical device industry.
Her work focuses on biological evaluations of medical devices in accordance with ISO 10993 and ISO 18562, as well as clinical and performance evaluations under EU Regulations 2017/745 (MDR) and 2017/746 (IVDR) and relevant MDCG guidance. She has also expanded NSF’s services in biostatistics and data analysis, supporting clinical investigations in line with ISO 14155 and MDCG 2024-3.
Silvia leads a team of specialists in clinical affairs and biological safety and regularly delivers technical training and presentations for industry audiences. She holds a PhD in Neuroscience from the Graduate Training Center of Neuroscience Tübingen and the International Max Planck Research School in Germany.
Learning Outcomes
Understand Regulatory Requirements for Statistics in Clinical Studies
- Regulation (EU) 2017/745 (EU MDR)
- ISO 14155
- MDCG 2024 3
Apply Core Statistical Concepts
- Determining samples and avoiding bias
- Understanding study designs and defining endpoints
- Working with measurement scales, measures of central tendency, and variability
- Distinguishing between frequency and probability distributions
Perform Statistical Analyses
- Formulating hypotheses and conducting hypothesis tests
- Applying statistical parameters
- Selecting appropriate statistical tests for different data types
- Conducting sample size estimation
- Analyzing and interpreting study data
Who Should Attend
- Medical device manufacturers
- Auditors and RPPCs (Article 15, MDR)
- Production personnel involved in clinical data processes
- Research and Development teams
Why You Should Attend
This course is ideal for professionals who need a solid understanding of biostatistics to plan, conduct, or evaluate clinical studies for medical devices. It equips participants to define meaningful endpoints, calculate sample sizes with confidence, and apply appropriate statistical methods. The training strengthens the ability to generate scientifically valid conclusions and prepares participants to meet regulatory expectations and justify statistical approaches during conformity assessment.
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