PMCF Data Collection: When Surveys Work, When They Don’t, and What Regulators Expect

Surveys have become widely used in post-market clinical follow-up (PMCF). But many MedTech teams are unsure when surveys are actually sufficient, when regulators expect stronger clinical evidence, and how to ensure the data collected is sufficient.

Questions like these come up frequently:

• When are surveys a valid PMCF data collection method?
• Can PMCF surveys truly be anonymized?
• What sample size is needed for statistically meaningful PMCF data?
• In Practice, Where Do High-Quality Surveys Provide the Most Value for MDR Compliance?

In this webinar, clinical and regulatory experts will explore where surveys fit within a PMCF strategy and where their limitations begin.

You will learn:

• When surveys are appropriate for PMCF data collection
• Situations where surveys alone may not provide sufficient evidence
• The realities of anonymized and pseudonymized PMCF data
• How to approach sample size and statistical significance in PMCF studies

Speakers

• Alessandro Malaspina, Head of Regulatory Affairs, 1MED
• Pall Johannesson, EVP Europe, Greenlight Guru

Join us to gain practical insight into designing PMCF programs that produce meaningful clinical evidence while meeting regulatory expectations.