If your company produces medical or health-related products, you need to know whether they meet the FDA’s definition of Class I medical devices—and, if so, you need to start now to implement UDI Rule requirements before enforcement begins on September 24.
The FDA has extended by two years key requirements related to its new unique device identifiers (UDI)—a move that amounts to a tacit acknowledgement that adoption and implementation of that tracking system for medical devices is more challenging than originally anticipated, according to the Association for the Advancement of Medical Instrumentation.
On 24x7 we have a poll to see what technology you use to eliminate or reduce manual data entry and/or the use of paper scratch sheets to log PMs or repair documentation. We offer three different choices, such as some type of Wi-FI enabled
Toshiba America Medical Systems Inc, Tustin, Calif, a developer of contrast-free magnetic resonance angiography techniques, has introduced time and space angiography, a fourth generation contrast-free imaging technique.
Read MoreThe European Parliament adopted more than 100 amendments to medical device directives that should pave the way for improved device regulation in the European Union.
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Read MoreGE donates intensive care monitoring system to college; FDA orders the seizure of unsafe hospital beds; Medrad Inc sales revenues grow; and more. GE Gives Lift to Biomed Tech Program GE Healthcare (Waukesha, Wis) has donated a complete inte
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Read MoreThe board of directors of the American College of Clinical Engineers (ACCE) believed that a nonprofit foundation would enable ACCE to reach professional goals and build upon the clinical engineering field’s foundation. ACCE created an exp
Read MoreFDA Releases Guidance, GE Receives Regulatory Approval for Instrumentarium, ECRI Evaluates Sharps Disposal Containers FDA Releases Guidance On August 19th, the US Food and Drug Administration issued a guidance for industry and FDA staff tit
Read MoreInstrumentarium closes on Spacelabs Medical Instrumentarium Corp. (Helsinki, Finland) on July 4 closed on its acquisition of Spacelabs Medical Inc. (Redmond, Wash.), paying $14.25 in cash per share to Spacelabs’ stockholders. Total value
Read MoreISO-9000 is a Better Alternative for Servicers and Remarketers
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