ARTICLE SUMMARY:
In this month’s spotlight from Pathways’ Document Depot, the International Medical Device Regulators Forum dropped five documents in May, advancing harmonized approaches in machine learning, cybersecurity, premarket review, and more.
Docs of the Month is a regular column highlighting key findings from Pathways’ 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.
When a national regulatory agency issues a new rule, guidance, or order, one thing is pretty clear: if your company operates or plans to operate in that market, you should dig into the details of that document ASAP to make sure you are meeting regulator expectations.
