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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
The U.S. Food and Drug Administration last month issued final guidance outlining the steps manufacturers of medical device software must take spurn cybersecurity threats. Read More
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
Manufacturers of nucleic acid amplification test reagents for dengue virus should take a variety of steps, such as optimizing reagents and test procedures for recommended instruments, to prevent false negative or positive results, the U.S. Food and Drug Administration says. Read More
Devicemakers or their authorized representatives must report serious adverse events involving their products to regulatory authorities immediately upon learning of a potential link, the Asian Harmonization Working Party says in updated draft guidance released last month. Read More
Given past experience with metal-on-metal joint replacements, the introduction of new prostheses should be both gradual and backed up by new and stronger preclinical and clinical studies, a panel of scientific experts in the EU says. Read More
India’s medtech industry could reach $50 billion by 2025 if comprehensive regulatory and reimbursement infrastructures are put in place, a new market research report says. Read More
South Korea’s Ministry of Food and Drug Safety is amending its standards for electromagnetic safety of medical devices to align them with international standards. Read More