IMDRF Flags Lack of ‘Global Alignment’ in Cybersecurity

Devicemakers should assess cybersecurity risks throughout the product lifecycle, the International Medical Device Regulators Forum (IMDRF) says in a new draft guidance… Read More

FDA Investigates Implantable Devices That Contain Metals

The FDA called for feedback on a newly released report on biological responses to metal implants and says it’s investigating possible adverse events linked to the devices. Read More

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