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Three months after the EU’s RoHS 2 deadline, Stryker has reviewed more than 600 products and dealt with “significant” costs to comply with the regulations. Fortunately, the company has had a relatively easy time finding alternative components when necessary. Read More
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
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
Western Enterprises/Scott Fetzer Company received an FDA warning letter after averaging its suppliers’ quality ratings with its delivery ratings, resulting in a higher overall rating for some suppliers. Read More
Devicemakers seeking authorization to market Class II products in Canada will need to submit labeling with their licensing applications, under draft guidance released Oct. 20. Read More
Manufacturers of low- and moderate-risk devices will soon be able to register their products in Australia based on CE mark certificates issued by European notified bodies, under a government action plan introduced this month. Read More