New: 360° PMCF Strategy Review

Post-Market Clinical Follow-up (PMCF) is the continuous process of pro-active clinical data collection of a CE-marked device. From the moment your device is placed on the market and used in clinical practice, real-world data are being generated. Qserve CRO can help you collect and use these data for life cycle management of your device. We are specialized in collecting clinical data in a practical and compliant manner for the benefit of (continued) CE-marking of medical devices.

Our experience with Notified Bodies and the regulatory requirements in Europe combined with hands-on clinical operational excellence will ensure high-quality clinical data that meets the regulatory requirements.

Selecting the appropriate PMCF methodology there are multiple options; clinical studies, registries, retrospective data collection, user surveys and others. Each method comes with its own spectrum of data quality, resource requirements, risks and benefits.

Contact us
Celien van Lochem

New: 360° PMCF Strategy Review

Post-Market Clinical Follow-up (PMCF) is the continuous process of pro-active clinical data collection of a CE-marked device. From the moment your device is placed on the market and used in clinical practice, real-world data are being generated. Qserve CRO can help you collect and use these data for life cycle management of your device. We are specialized in collecting clinical data in a practical and compliant manner for the benefit of (continued) CE-marking of medical devices.

Our experience with Notified Bodies and the regulatory requirements in Europe combined with hands-on clinical operational excellence will ensure high-quality clinical data that meets the regulatory requirements.

Selecting the appropriate PMCF methodology there are multiple options; clinical studies, registries, retrospective data collection, user surveys and others. Each method comes with its own spectrum of data quality, resource requirements, risks and benefits.

Contact us
Celien van Lochem

PMCF data can only be used for regulatory purposes when the PMCF activity has been properly designed and is of high quality, with well-defined clinical endpoint(s), that collect data on the clinical safety and performance of the device in scope.

Key components in the development of high-quality PMCF activities are:

  • Clear scope
  • Appropriate design including research questions, objectives, endpoints
  • Evaluation of potential sources of bias or study distortion
  • Statistical justification, statistical analysis plan, acceptance criteria
  • Data analysis plan and a plan for drawing appropriate conclusions
  • Accessibility and responsiveness of appropriate target population

Are you working on your PMCF plan and you have questions? Or would you like to verify your thoughts with us? We offer our 360o PMCF strategy review for a fixed price of EUR2450 per product. We will review your PMCF plan, evaluate your set-up in line with your products CER and IFU, provide our feedback on any related documentation, e.g. protocol (synopsis), survey, registry plan etc.

Contact | Celien van Lochem

BD manager Qserve CRO would be happy to receive your request.
celien.van.lochem@Qservegroup.com
+31682180286