Medical Innovation Exchange

Product Management

510k Submission Planning

510k Submission Planning     With an aim to provide thoughtful insight on how to go about planning a 510(k) submission long before the writing begins, we have created this helpful list of top tips, where we will outline the items you should be aware of when planning your 510K submission. Tip #1: Visit the FDA …

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CitiusTech Appoints Sudhir Kesavan as Chief Operating Officer

CitiusTech Appoints Sudhir Kesavan as Chief Operating Officer     Sudhir Kesavan is the new Chief Operating Officer (COO) of CitiusTech, a provider of healthcare technology services, solutions and platforms. In his new role, he will assume responsibility for leading CitiusTech’s global delivery organization. This will encompass enhancing practice capability, service delivery maturity, market innovation to drive …

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Baxter Advances IV Bag Recycling Pilot for U.S. Hospitals

Baxter Advances IV Bag Recycling Pilot for U.S. Hospitals     Baxter International announced that it has completed the first phase of its intravenous (IV) bag recycling program pilot and is now expanding the pilot program. Launched in conjunction with Northwestern Medicine in Chicago, the program has diverted more than six tons (or 12,000 pounds) of …

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Digital Continuity: Strategies for Product Recall Resilience

Digital Continuity: Strategies for Product Recall Resilience     The mission to bring meaningful innovation to market and improve patient lives is paired with the requirement that such innovations are held to the highest quality. There were 70 class I U.S. medical device recall events in 2022, a category that the FDA reserves for problems that …

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