Medical Device Regulatory Requirements - New Japanese Guidelines

Medical Device Regulatory
Japan’s medical device market is one of the most robust markets in Asia, but its regulatory system can prove confusing. Before deciding to sell your device in the Japanese market, it is important to understand how the regulations apply, which steps to take.
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Spotlight

OTHER ON-DEMAND WEBINARS

New US FDA Guidance on HFE for Medical Devices

In this webinar, the presenters help attendees better understand the decision points they might face when determining a submission category and examine the examples provided by the FDA.
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Scripps Health and HIMSS Share New Insights into IT-Driven Clinical Process Efficiencies

HIMSS Learning Center

Clinicians are under an increasing time burden to care for patients. Even under the best circumstances, technologies implemented to automate and streamline workflows may not achieve the right balance to deliver as promised and improve effectiveness, efficiency, and job satisfaction.
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Managing User Adoption in Informatics Projects

Siim

Given the number and diversity of people affected, deploying or replacing clinical IT infrastructure is never easy. Add to that, a financial incentive tied to the commercial success of the product your implementing and you amplify the complexity. Proper change management is critical to ensure a positive user experience and acceptance of a new system.This webinar will focus on a PACS replacement project at a large hospital system and the development of a scalable, repeatable strategy for site readiness and change management for go-lives with a focus on operational success as well as product acceptance.
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Unify ALL of Your Systems of Care to Improve Patient and Financial Outcomes

Pulsara

Poor communication contributes to 80% of medical errors (the 3rd leading cause of death), ⅓ of all malpractice suits, poor outcomes and redundant costs. Unfortunately, these miscommunications are abundant because our care teams are stuck in communication silos. That's why we need to unify ALL systems of care for ALL time sensitive emergencies with regional communication networks that connect ALL members of the care team -- from prehospital providers to interfacility teams to those at other hospitals outside of our own.
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