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A medical device manufacturer in Yokneam, Israel failed to submit adverse event reports to the FDA within 30 days after becoming aware of numerous complaints that warranted them, the agency said. Read More
Developing classification guidance for IVDs, and industry guidelines for assigning unique device identifies are some of the actions categorized as high priorities. Read More
As the EU implements its new medical device and IVD regulations, the association is urging the UK to remain aligned with the EU27 regulatory system. Read More
No training was provided to the executive assistant who had been conducting quality audits at the firm’s manufacturing facility, an FDA investigator said. Read More