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Companies will need to report within 48 hours from discovery if a medical device sold in Malaysia presents a serious threat to the public health according to new requirements released by Malaysia’s Medical Device Authority. Read More
A new study of the four biggest makers of pacemaker systems found thousands of software vulnerabilities, highlighting an industry-wide problem with software security updates. Read More
Despite a pressing need in the device sector for postmarketing surveillance, studies remain infrequent and limited in scope, and though the FDA has envisioned a robust system using medical records to track device safety, any such system is years from adoption, would need additional funding, and may not survive the new administration’s interest in deregulation. Read More
The proposed amendment to the country’s Food & Drugs Act would require full incident reports to Health Canada from any hospital that provides acute care products. Read More