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SSCP: the document that makes a medical device’s safety visible. It’s not just a technical file—it’s a tool for public…
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?
