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Regulatory affairs
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…
According to the MDR Regulation, the technical documentation must be complete, well-structured, and contain sufficient information to demonstrate that the…
Biological evaluation is a crucial aspect of medical device development. It should first be addressed during the design verification phase…
The Procedure Pack File for medical device systems and procedure packs, as well as the Technical Documentation for IVD kits,…
