The new article describes in detail certain specific aspects related to post-market surveillance – in particular, the way the authority is going to communicate...
The new article describes in detail specific aspects of electromagnetic compatibility, including the ones related to modifications and labeling. Table of ContentsThe Food and...
In this article we will go through Article 110 of EU IVDR 2017/746.
We have already been discussing about the requirements associated to legacy devices, specifically in...
Researchers from the University of Edinburgh in the UK have developed a tool that uses artificial intelligence (AI) to merge patient data with blood...
Roche has introduced a human papillomavirus (HPV) self-sampling solution in countries accepting the CE mark in order to extend screening options for cervical cancer.
Screening for HPV...
Senseonics has obtained CE mark approval for its next-generation Eversense E3 continuous glucose monitoring (CGM) System, which can be used for up to six...
The new article provides an overview of the Essential Principles for specific types of medical devices, such as active medical devices, the ones with...
NMPA issued the “Clinical Pathway Recommendations for Certain Categories of Medical Devices” on June 16, 2022. The document suggests manufacturers how to choose clinical...
We want to share the highlights of China regulatory submission case from NMPA reviewers’ perspectives on positron emission/X-ray computed tomography (PET/CT system). Both technical...
