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

Miami Children's Health System

A World Leader in Pediatric Healthcare. Founded in 1950 by Variety Clubs International, Nicklaus Children's Hospital, formerly Miami Children's Hospital, operates South Florida’s only licensed specialty hospital exclusively for children, with more than 650 attending physicians and over 130 pediatric sub-specialists.

OTHER WHITEPAPERS
news image

How Healthcare Organizations Must Respond Urgently in the Digital Age

whitePaper | January 13, 2020

Today, healthcare organizations are witnessing a major shift in power. The industry is realigning itself increasingly around the priorities of patients. The change is unstoppable — and healthcare companies must act swiftly to avoid getting left behind.

Read More
news image

Testing the EMR and Beyond

whitePaper | October 5, 2021

At every stage of a patient’s well-being, different forms of technology and software support the expansion of better healthcare. As the reliance on technology grows, ensuring that these lifesaving systems don’t break under the strain is imperative. To keep operations running smoothly, healthcare IT professionals must perform regular and exhaustive testing. Fortunately, the introduction of automation, robotics, and artificial intelligence (AI) has made testing easier to deliver. In this eBook, you will discover how these technological developments help optimize processes, integrate workflows, and improve the performance of systems and medical devices.

Read More
news image

Reimagining healthcare IT for the next decade

whitePaper | March 2, 2020

In the decade since the HITECH Act was passed, first-generation electronic health record systems provided a foundation for innovations such as electronic prescribing, clinical decision support and predictive analytics. While usability and productivity issues with EHRs have been well documented, there are significant untapped opportunities to optimize the EHR and health IT. In this whitepaper, PatientKeeper outlines a vision for the future of health IT through the next decade, which includes New data-driven approaches that leverage the clinical information being captured by the EHR to improve patient outcomes and reduce physician burnout, Optimized communication between physicians, nurses and ancillary staff to produce better patient outcomes as efficiencies improve, Better interoperability to improve care coordination and inspire opportunities for ideas like telemedicine to alleviate physician shortages

Read More
news image

Protecting Privacy in the Cloud and Cyber Resiliency Are Key for Healthcare Organizations

whitePaper | October 26, 2021

James Angle, Ph.D. of Trinity Health and Erin Logue Smith of Dell Technologies provided timely information on cybersecurity in a Healthcare Innovation webinar as ransomware threats makes it mandatory tosystematically elicit and mitigateprivacy threats in software architectures.

Read More
news image

How healthcare organizations tackled challenges with Google Cloud

whitePaper | April 26, 2021

In this paper, explore how to tackle data interoperability challenges, stringent regulations, security requirements, and growing patient expectations in healthcare with Google Cloud. Open now to see four case studies and follow along on the organizations’ challenges, solutions, benefits and final results.

Read More
news image

7 Steps to Help Prevent Ransomware Attacks against Healthcare Delivery Organizations

whitePaper | November 17, 2021

Nearly every healthcare provider has been hit by ransomware, and the onslaught continues unabated, now affecting patient care with once-unimaginable patient-care consequences. This whitepaper, crafted with healthcare CISOs, details seven critical areas to defend or recover from ransomware attacks. Its pragmatic approach helps ensure business operations and patient care while giving risk teams the tools to manage third parties and other systems involved in business and clinical value chains.

Read More

Spotlight

Miami Children's Health System

A World Leader in Pediatric Healthcare. Founded in 1950 by Variety Clubs International, Nicklaus Children's Hospital, formerly Miami Children's Hospital, operates South Florida’s only licensed specialty hospital exclusively for children, with more than 650 attending physicians and over 130 pediatric sub-specialists.

Events