Updated: Feb 27, 2020
IMDRF: Guidance drafted on regulatory pathways for personalised medical devices
IMDRF: Comments solicited on terminologies for categorised adverse event reporting
ISO: Clinical performance studies for IVDs addressed in new ISO standard
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The WCO reminds the general public to exercise extreme caution when purchasing critical medical supplies from unknown sources, particularly online. The use of these goods may cost lives. While the wor
The World Health Organization (WHO) supports the implementation of reliance on other regulators’ work as a general principle, making optimal use of available resources and expertise. When built upon G
AHWP: Proposed competency framework for medical technology regulators IMDRF: Principles and practice for medical device cybersecurity are drafted IMDRF: Requirements for Regulatory Authority recogniti
