Docs of the Month: Software Guides on Parade

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Multiple guides and flowcharts intended to help walk companies through how to know when a piece of software is regulated as a device or IVD, and how heavily, were issued by medtech regulatory agencies in July, according to Pathways’ Document Depot.

Docs of the Month is a regular column highlighting key findings from Pathway’s Document Depot, a database of global medtech regulatory and policy official documents, including rules, guidance documents, memos, white papers, and more from national authorities, non-governmental groups, and global organizations.

Teasing out how to fit health software into device regulatory frameworks remains one of the most dynamic areas of focus for medtech agencies around the globe. That fact shined through in the month of July, when agencies from four different countries posted resources to parse the digital health landscape, as tracked by Pathways’ Document Depot.


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