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Sora Lifesciences
Global dental device manufacturer

PMCF survey for endodontic paper points

A global dental device manufacturer engaged us to run a post-market clinical follow-up survey among dentists in the US and EU5, capturing clinician-reported evidence on the performance, safety, and usability of its endodontic paper points.

Key offerings in this project
  • PMCF Survey

The brief

  • Generate clinician-reported evidence on real-world performance and safety for post-market surveillance.
  • Capture usability, canal drying performance, sizing adequacy, and IFU clarity in routine practice.
  • Identify any residual risks, issues, or unforeseen risks to patients and users.
  • Deliver a clean, structured dataset ready to feed the PMCF report.

The problem

No current clinician-reported evidence on real-world performance, safety, and IFU clarity for post-market surveillance

Our approach

A structured PMCF survey of 96 licensed dentists across the US, UK, France, Germany, Italy, and Spain, run under MRS code of conduct

  • Designed a screened questionnaire covering brand and product usage, experience, performance, IFU, and safety.
  • Fielded online to 96 licensed dental professionals across the US and EU5 markets.
  • Screened on licensing, job role, and current use of the client's paper points before entry.
  • Built in an adverse-event and complaint reporting route, with confidentiality safeguards throughout.

Key outcomes

A clean, analysis-ready dataset covering performance, usability, IFU clarity, and safety, with adverse-event flagging

  • Captured 96 completed responses across six markets within the fielding window.
  • Quantified agreement on ease of use, reliability, complete drying, sizing, and IFU clarity.
  • Measured issue rates, canal fit, drying time, and likelihood to recommend.
  • Delivered a cleaned, coded raw data file ready for PMCF reporting and trend analysis.

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