Brazil’s regulator Anvisa has suspended selected medical devices after identifying packaging defects that could compromise ...
The U.S. FDA and the U.K.’s Medicines and Healthcare products Regulatory Agency agreed to bolster their ongoing medical ...
Health regulators on both sides of the Atlantic are assessing alignment opportunities and exploring mutual recognition ...
WASHINGTON (AP) — U.S. health officials on Tuesday proposed steps to improve the government's system for overseeing medical devices, which has been criticized for years for failing to catch problems ...
The FDA has entered into the federal register a new draft guidance pertaining to "software as a medical device" (SaMD). The guidance is presented as representing the FDA's current thinking on ...
As MDR and similar regulations shape global market access, certified devices are likely to gain further traction relative to uncertified alternatives. Careboo’s development within MDR-compliant ...
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