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Australia’s Therapeutic Goods Administration has published guidance explaining the regulatory requirements for medical devices that are packaged together.
Japan’s efforts to improve regulation of pharmaceuticals and medical devices and speed the introduction of advanced technologies include the decision to regularly accept data from foreign clinical trials, according to a recent report on the U.S.-Japan Regulatory Reform and Competition Initiative.
A revised version of ISO 14969 will be published within the next month, providing guidance on implementing the quality management aspects of ISO 13485:2003, according to a member of the working group that revised the standard.
Devicemakers do not have to substantially revise ISO 13485-compliant quality management systems (QMS) to meet the FDA's quality system regulation (QSR) because the standard does not set up conflicting requirements, according to David Feigal, director of the Center for Devices and Radiological Health (CDRH).
Devicemakers need to focus on one language at a time when translating their websites for foreign audiences because the lessons learned developing one website will save time during the translation of subsequent sites.