Although Regulation (EU) 2017/745 on medical devices (MDR) does not explicitly mention surveys, they are recognized in applicable standards and guidelines as valid methodologies for data collection, particularly within Post-Market Clinical Follow-up (PMCF) activities. The use of surveys is especially beneficial when a moderate level of clinical evidence is required…
News & Stories
Be informed and inspired by our weekly insights. An original perspective on regulatory affairs and quality assurance for medical devices and in vitro diagnostic medical devices, scientific communication and medical writing for the entire life science sector.
Subscribe to Clariscience Magazine
Be informed and inspired by our weekly insights. An original perspective on regulatory affairs and quality assurance for medical devices and in vitro diagnostic medical devices, scientific communication and medical writing for the entire life science sector.
Although Regulation (EU) 2017/745 on medical devices (MDR) does not explicitly mention surveys, they are recognized in applicable standards and…
PMCF surveys are effective tools for collecting post-market clinical evidence quickly, sustainably, and in compliance with the MDR, when well…
IEC 62366-1 provides a structured approach to evaluating the usability of medical devices.Reducing use-related errors means enhancing both safety and…
Discover how to build an Oscar-worthy clinical evaluation for your medical device: a solid CER, robust data, and an expert…
The European Union is accelerating its efforts in biotechnology and biomanufacturing with an integrated strategy aimed at strengthening innovation, sustainability,…
The bibliography of a clinical protocol serves to demonstrate that the protocol is built on a solid foundation of existing…
The introduction of an article is meant to…introduce what has been done! But what structure can we give it?
Randomization is a statistical procedure that, when applied in clinical studies, assigns participants to different treatment groups randomly.
