PMCF Sample Size Calculator

Sample size calculation is one of the most scrutinized elements of a PMCF plan. Get it wrong and you risk underpowered studies, Notified Body pushback, or enrollment targets that are impossible to hit.

This calculator handles the statistics so you can focus on the clinical rationale. Enter your expected rates, choose your study design, and get a defensible sample size range with a downloadable audit record you can drop directly into your PMCF plan documentation.

What you get:

• Three-tier results showing minimum viable, recommended, and conservative enrollment targets
• Direction-aware formulas for event rates and clinical success rates
• Built-in adjustments for dropout, subgroups, and follow-up duration
• A PDF audit record with step-by-step derivation, regulatory references, and a justification checklist aligned to MDCG 2020-7

Fill out the form to access the calculator. Our clinical team will also follow up to hear whether it was helpful and to learn more about your upcoming PMCF studies.

Disclaimer: 
Always consult a qualified biostatistician before initiating any clinical study. The sample sizes generated by this calculator are statistical estimates based on the inputs you provide and the assumptions behind each formula. They are not a substitute for professional biostatistical review.

Never use these results as-is for a clinical study, regulatory submission, or PMCF plan without independent verification. A biostatistician should review your study design, validate the assumptions, confirm the appropriateness of the chosen formula, and sign off on the final sample size before enrollment begins.