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Clinical data collection for medical devices: the role of PMCF surveys

16 September 2025
Federica D'Incà
Although Regulation (EU) 2017/745 on medical devices (MDR) does not explicitly mention surveys, they are recognized in applicable standards and…
Regulatory affairs

Survey PMCF: how to collect post-market clinical evidence effectively and in compliance

16 September 2025
Valentina Tomaello
PMCF surveys are effective tools for collecting post-market clinical evidence quickly, sustainably, and in compliance with the MDR, when well…
Regulatory affairs

IEC 62366-1: A Practical Guide to Usability Evaluation of Medical Devices

11 September 2025
Margherita Fort
IEC 62366-1 provides a structured approach to evaluating the usability of medical devices.Reducing use-related errors means enhancing both safety and…
Regulatory affairs

If your clinical evaluation were a movie, would it win an Oscar?

11 September 2025
Elena Zucchini
Discover how to build an Oscar-worthy clinical evaluation for your medical device: a solid CER, robust data, and an expert…

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