Clinical Data for Medical Devices

To market a medical device in the EU, a manufacturer must demonstrate that the device is safe, that it performs as intended, and that the risks associated with the use of the device are acceptable when weighed against the benefits to patients. Clinical evaluation is the assessment and analysis of clinical data pertaining to a medical device to verify its clinical safety and performance. It may be based on a literature review and/or clinical experience and/or clinical investigations...

Spotlight

Glytec

Founded in 2006, Glytec is the pioneer and leader in diabetes therapy management software, enabling healthcare organizations to standardize acute and chronic care, and achieve best practice for glucose control. The company’s comprehensive eGlycemic Management System® (eGMS®) has been proven to dramatically reduce the drivers of cost and clinical variation, including hypoglycemia, readmissions, length of stay, complications and A1C levels. Its efficacy and safety have been validated by more than 60 research studies. eGMS® centers on an FDA-cleared insulin dosing solution that supports personalized intravenous and subcutaneous therapy for adult and pediatric populations.

OTHER WHITEPAPERS
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The State of Healthcare Performance Improvement

whitePaper | November 8, 2019

The report provides healthcare leaders with 4 actionable strategies, supported by successful practices that combine performance improvement tactics, technology and survey of hospital and health system leaders on the state of performance improvement and cost transformation efforts within their organizations.

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Australia’s health reimagined

whitePaper | March 11, 2022

Following the emergence of COVID-19 and significant foundational investment in digital health infrastructure, Australia’s health system, like all health systems globally, is rapidly building momentum towards a digital future.

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THE FUTURE OF TELEHEALTH ROUNDTABLE

whitePaper | May 12, 2022

The advent of COVID-19 brought numerous challenges to care delivery, forcing health professionals to think innovatively to facilitate timely care while maintaining compliance with shelter-in-place ordinances.

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The Impact of Ransomware on Healthcare During COVID-19 and Beyond

whitePaper | November 17, 2021

The pandemic hit the healthcare industry hard, but it also weakened the cybersecurity defenses of most providers, making them far more vulnerable to threats such as ransomware. This report, covered across national news, is considered the most significant actionable cybersecurity research over the past several years because it also documents the severe impact on patient care. This executive summary includes critical areas that providers can address starting today.

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Improve Clinical Workflow, Reduce Costs with Purpose-Built Devices for Healthcare

whitePaper | February 6, 2020

Improving telehealth success with Healthcare specific devices. One of the primary challenges faced by clinicians with telehealth appointments is effectively and efficiently bringing both parties together without any breakdown in communication. Therefore, it's imperative that the hardware being utilized can support excellent audio with noise cancelling features, hi-res video and integrated hi-def cameras - without these items’ physicians are left with a good idea of the issue at hand but no way to implement.

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Healthcare Payment Predictions - What You Need To Know

whitePaper | October 1, 2021

Today’s healthcare consumers want to pay their medical bills anywhere, anytime. They’re looking for estimates, payment plan options, and payment mechanisms to be at their fingertips across multiple channels. They can pay for almost anything they desire from their laptops and mobile devices, so why should healthcare be any different? What do providers need to know to build a healthcare payment solution that’s fit for purpose today and into the future? Experian Health’s patient payment experts make seven predictions for healthcare payments that will help providers boost consumer loyalty and revenue.

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Spotlight

Glytec

Founded in 2006, Glytec is the pioneer and leader in diabetes therapy management software, enabling healthcare organizations to standardize acute and chronic care, and achieve best practice for glucose control. The company’s comprehensive eGlycemic Management System® (eGMS®) has been proven to dramatically reduce the drivers of cost and clinical variation, including hypoglycemia, readmissions, length of stay, complications and A1C levels. Its efficacy and safety have been validated by more than 60 research studies. eGMS® centers on an FDA-cleared insulin dosing solution that supports personalized intravenous and subcutaneous therapy for adult and pediatric populations.

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