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Devicemakers need to be vigilant against possible embedded medical device software vulnerabilities as the FDA continues to develop a formal cybersecurity strategy, a security expert warns. Read More
Devicemakers are urging the incoming president of the European Commission to clarify once and for all whether medical technologies will continue to be overseen by the directorate for health or move to industry, as previously proposed. Read More
Abbott’s $250 million purchase of Topera, announced Wednesday, has significant implications for both Abbott and other devicemakers in the atrial fibrillation space, analysts say. Read More
Using QSIT for internal audits could put devicemakers in a much stronger position when FDA investigators coming knocking on the door, compliance experts agree. Read More
Recent FDA guidance on distributing scientific publications that cover off-label uses is out of touch with today’s data-driven economy and should be modified to embrace digital communication platforms, a Washington, D.C. think tank says. Read More
CDRH is steadily chipping away at PMA and 510(k) review times, but the improvements are not enough to make the US competitive with the EU, which sets a far lower bar for approving new devices. Read More
Cook Medical is under FDA pressure to fix sweeping quality problems at its Indiana facility with the way it addressed more than 735,000 manufacturing noncomformances over a two-year period. Read More
As EU notified bodies begin conducting the unannounced audits required by the European Commission, devicemakers need to make sure they have at least two employees who are prepared to handle an audit. Read More
Medtronic Ireland failed to submit MDR reports within 30 days of becoming aware of an event, including two that involved the death of a patient, according to a May 15 Form 483, recently released. Read More