ARTICLE SUMMARY:
Standards are foundational tools for making, testing, and using medical technology. Here are some noteworthy standards recently published, according to tracking by Document Depot, as well as recently recognized standards and new items in the works.
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.
Cadres of technical experts are working year-round to spell out and reach agreement on the best practices for designing, manufacturing, testing, and implementing products and processes. The resulting standards documents, created by the International Organization for Standardization (ISO), the International Electrotechnical Commission (IEC), the Association for the Advancement of Medical Instrumentation (AAMI), and an array of other groups, help form the basis for how companies develop new medical devices and maintain existing ones.
