The FDA has announced plans to transition to standard ISO 13485:2016 for medical devices in 2019. In addition, the Medical Device Single Audit Program, MDSAP, has gained traction with full implementation set for 2019.
Download this paper to learn more about these two changes from the U.S. Food and Drug Administration’s proposal to harmonize and modernize its Quality System Regulation (QSR).
Leading medical devices company were facing business continuity post acquisition, thereby increasing maintenance costs accordingly. LTI proposed to implement Oracle Fusion Cloud which helped in faster and minimal requirement of technical manpower.
i. In-time Delivery with ZERO defects
ii. Scalable products with low maintenance costs
Download full case study.
Published By: Maetrics
Published Date: Oct 08, 2015
Re-evaluating Their Importance Under a New Regulatory Spotlight
Every medical device sold into Europe, irrespective of its classification, must have an up-to-date Clinical Evaluation Report (CER) as part of its Technical File.
ABI Research’s Securing Medical Devices Technology Analysis Report analyzes the current risks posed by medical devices, noting various security issues, potential vulnerabilities, and the threat landscape. It reviews implementation mechanisms and efforts in medical device cybersecurity and safety. The final section looks at how the healthcare ecosystem is responding to the issues and the vendors driving change.
The network has never been as critical to the healthcare sector as it is today. Electronic health records, Wi-Fi-connected medical devices, and clinician smart phones are among a plethora of healthcare technologies that depend on a stable network.
The consistent development of this infrastructure is key for the healthcare sector to continue its successes in creating new possibilities for management, patient and family experience, and patient outcomes.
Extreme Networks posed key questions to Nolan Greene, a senior research analyst with IDC’s Network Infrastructure group, who highlights the critical issues healthcare IT professionals must consider when building a network that maintains industry needs.
Download this report to learn about:
• Why having a modern healthcare infrastructure is so important
• The major challenges IoT brings to healthcare networks
• How IEC 80001 is impacting compliance
• Trends that confront a network IT professional in healthcare
• Risks Healthcare IT must eli
For today’s service providers and enterprises, bandwidth demands continue to increase and evolve. The introduction of Internet of Things (IoT) solutions, such as smart homes, smart cities, connected cars, and connected medical devices, is forcing organizations to change existing business models and to build more cost-effective networks.
Leading medical devices company were facing business continuity post acquisition, thereby increasing maintenance costs accordingly. LTI proposed to implement Oracle Fusion Cloud which helped in faster and minimal requirement of technical manpower. Download complete case study.
Semiconductors run and connect today’s technology-driven world, powering all the electronic systems and products around us. Critical to communication, entertainment, work, medical diagnoses, travel, socializing, and making new discoveries, these specialized chips are ubiquitous. And chip designs grow ever more sophisticated in order to power new generations of devices, computers, the Internet, and the cloud. To enable new applications and use cases – like the Internet of Things – semiconductor vendors have continually pushed the boundaries of their designs to accommodate new fabrication processes that make chips smaller, more power efficient (to make personal devices last longer), and able to pack more gates into smaller dies (to make them more powerful).
Digital transformation and smart technologies are paving the way towards smarter healthcare. Medwel understands that the goal of smart hospital development stems from the needs of the patient. By tapping on ICT advancements in the healthcare environment, the common goal is to reduce medical errors and achieve a holistic approach centered on the patients’ needs.
Read more about the new MEDS-P1001—a 10.1” medical grade touchscreen PC that boosts
• Effective computing through low power consumption
• Interoperable through dual OS for different applications in hospitals
• Health insights based on smart interfaces of vital sign measuring devices
• Expandable functions through peripheral devices such as cameras, RFID reader, WIFI, etc.
• Refined and reliable design that is slim, lightweight, antibacterial, water and dust-proof
With the proliferation of health and fitness data due to personal fitness trackers, medical devices and other sensors that collect real-time information, cognitive computing is becoming more and more important. Cognitive computing systems, with the ability to understand, reason and learn while interacting with human-generated data, enable providers to find meaningful patterns in vast seas of information. IBM Watson Health is leveraging the power of cognitive computing to help providers make data-driven decisions to improve and save lives worldwide, while controlling healthcare costs. Read our whitepaper and learn about the new era of cognitive computing and how it can improve health outcomes, optimize care and engage individuals in making healthy choices.
Published By: MarkLogic
Published Date: May 07, 2018
Learn how Life Sciences organizations can accelerate Real World Evidence by achieving faster time to insight with a metadata-driven, semantically enriched operational platform.
Real World Evidence (RWE) is today’s big data challenge in Life Sciences. Medical records, registries, consultation reports, insurance claims, pharmacy data, social media, and patient surveys all contain valuable insights that Life Sciences organizations need to ascertain and prove the safety, efficacy, and value of their drugs and medical devices.
Learn how Life Sciences organizations can accelerate RWE with a metadata-driven, semantically enriched operational platform that enables them to:
• Unify, harmonize and ensure governance of information from diverse data sources
• Transform information into evidence that proves product efficacy and safety
• Identify data patterns, connections, and relationships for faster time to insight
Our active and actively aging population is the dichotomy
fueling significant growth for implantable medical
devices. Innovations focused on mobility, engagement and
quality of life are directly targeting this growing population.
The implantable medical device industry is poised to capitalize on these unique needs, while simultaneously
meeting unprecedented cost pressures. It is time for manufacturers to seek expertise in inventory management
and logistics for greater visibility, control and profitability.
For implantable medical device manufacturers to be as active and healthy as the patients they serve, their
future depends on the ability to differentiate products — not only by price, but through cost, service and
documented outcomes. New trends in personal health tracking keep patients moving, and data collection
will similarly improve the health of your business.
"Only 51% of device makers follow guidance from the FDA to mitigate or reduce inherent security risks. See how hospitals can harness the benefits of connected medical devices to achieve operational efficiencies, provide better patient care and reduce the overall risk to patient safety. Watch this on-demand webinar to discover: • Emerging issues and trends that are risky to healthcare IT systems and can directly affect patient safety, violate their trust and impact revenue
• Best practices for shoring up network security blind spots with real-time asset inventory, network authentication and automated enforcement controls
• Why real-time endpoint visibility is the key to achieving an effective and proactive cybersecurity strategy"
Published By: Tripp Lite
Published Date: May 17, 2016
While the use of power strips in healthcare and medical facilities is common, the misuse of these devices is also common. Such misuse can result in citations, fines, or even patient injury at your facility.
This white paper covers:
• Common mistakes in the use of power strips
• Ways to avoid making the common mistakes
• How to develop and implement a power strip policy to ensure that your facility complies with codes and standards while reducing risk to patients and staff
Protecting patients, their PHI and your organizational data is mission critical. With almost 15 network connected IoMT devices per bed having an accurate inventroy, minimizing cybersecurity risks, protecting patients & their PHI data is critical.
The Internet of Things (IoT) is connecting our world in ways that were unimaginable 10 years ago—collecting data on everything we do and using it to streamline our daily activities. In doing so, IoT is changing the way that consumers think about service. Service organizations must be prepared to support these new customer expectations to ensure continued satisfaction to strengthen and foster loyalty.
Additionally, IoT is making its way into the enterprise, especially among organizations in industries like utilities, oil and gas, medical devices, manufacturing and telecommunications. Connected devices enable more efficient processes for maintenance and repair by constantly providing information on machines’ performance, environmental conditions, and possible failures. For example, a connected washing machine in a customer’s home could automatically send out an error report to the manufacturer when it experiences a failure. This is where field service management comes in.
Imagine: Your pharmaceutical or medical device has been tested in carefully designed
clinical trials and shown to meet required standards of efficacy and safety. It has gained
regulatory approval and has gone to market. Now you want to know, does it measure
up to its promise when used in the real world? Does it materially improve patient
outcomes? Does it outperform alternative therapies? Does it achieve these outcomes at
an appropriate value? Do you know which patients are most likely to benefit from it?
Can you prove it, with statistical rigor?
As the health care system moves toward a patient-centric, value-based approach,
questions such as these are getting heightened scrutiny from all angles – from regula-
tors, payers, providers and patients. And they should. Real-world evidence (RWE) can
provide new insight into the benefits, risks and cost effectiveness of medicines and
medical devices in actual use – evidence that can enable life sciences companies to
develop better therapies
Rush University Medical Center (Rush) is a not-for-profit healthcare, education, and research enterprise with a 664-bed academic medical center that includes hospital facilities for adults and children. Rush offers residency and fellowship programs in medical and surgical specialties to more than 2,000 students. With a large and experienced IT team, Rush manages three data centers across its campuses. The organization currently supports approximately 1,600 virtual desktops and 600 virtual servers, along with 10,000 physical desktops. The Rush IT team is tasked with supporting users on all devices, including smartphones and tablets. Watch the video to see how Rush protects the entire organization and protects against advanced threats with Trend Micro solutions, including Deep Discovery.
Webinar Brought To You By CDW-Trend Micro
Learn about a solution for electronics manufacturers to promote greater efficiency and profitability, as well as consumer satisfaction.
The full spectrum of IoT electronics consists of Medical Devices, Consumer electronics and appliances, network equipment providers and many more. “These “smart, connected products”—made possible by vast improvements in processing power and device miniaturization and by the network benefits of ubiquitous wireless connectivity—have unleashed a new era of competition.”