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QualOptima for Medical Devices

Medical device manufacturers and vendors, coordinated with the clinicians and their patients using them, are empowered by the QualOptima Outcomes System© to monitor and achieve value-driven optimal outcomes.  As health care transitions to value-based payment, relying on performance, outcomes and patient experience, the proven expertise and technology is embedded in the universal informatics platform QualOptima for data collection, monitoring and analytics, including predictive modeling and adverse event HFACS (Human Factors Analysis & Classification System) methodologies.  Quture offers the QualOptima Global Registry for all types of medical devices, such as an implant, apparatus, appliance, instrument, software, or material, intended by the manufacturer to be used for human beings, whether used alone or in combination.

QualOptima is available to the total spectrum of medical devices in all three (3) classes as regulated in the United States, as well as those regulated in Canada, the European Union (EU), the European Free Trade Association (EFTA) and Australia.


QualOptima Outcomes System

The primary purpose of the QualOptima Outcomes System© for medical devices is to monitor and evaluate the outcomes of these “devices” in various precision, value-driven, evidence-based medicine modalities of diagnosis, treatment, prevention, and/or monitoring, whether used alone or in combination.  Optimal clinical processes of care and patient-centered care plans utilizing medical devices lead to continuous development of evidence-based protocols for treating patients. The unique precision medicine functionality of QualOptima utilizes patient-specific risk, wellness and fitness factors (Quture’s meFactors©) to calibrate clinical performance and outcomes metrics.

Secondary purposes of the QualOptima Outcome System© include analysis and publication of results, patient education and cost-effectiveness of treatment procedures and products.

  • Value and patient experience analytics associated with different interventions
  • Empower clinicians & patients to select optimal care plans with remote monitoring
  • Engage patients throughout the continuum of treatment
  • Quantify patient outcome & functional performance measurement
  • Predictive modelling for personalized post-treatment functional performance
  • Comparative patient outcomes and value analytics imposing clinical and financial variables selection utilizing filters and algorithms
  • Resource use analytics for procedure times, personnel, co-morbidities, cost effectiveness
  • Evaluate and continuously learn from patient complications
  • Engage, advance and lead in the value-based payment model of the healthcare performance ecosystem

For more information see QualOptima Medical Devices Outcomes System


QualOptima Image Machine Learning System

The QualOptima Image Machine Learning System© for deep learning and image analysis of the full array of radiological images.  QualOptima implements state-of-the-art predictive modeling tools and algorithms.  Medical diagnostics and disease interception become faster, more accurate, and more accessible. These technologies can be combined with natural language processing (NLP) and unsupervised learning to provide the tools that allow physicians to fully utilize the vast stores of electronic medical data, both structured and unstructured regardless of what form they are in, such as dictated narrative doctors’ notes, structured laboratory tests and pathology reports.


QualOptima HFACS for Adverse Events

Monitoring and evaluating outcomes inevitably includes a method to track and analyze adverse events involving medical devices.  The FDA monitors reports of adverse events and other HFACSproblems with medical devices.  Significantly, this process alerts health professionals and the public, when needed, to ensure proper use of devices and the health and safety of patients. Medical device manufacturers and vendors want to be engaged with tracking adverse events and prevention long before they make the FDA medical device recalls list and other FDA safety communications available to consumers at DICE@fda.hhs.gov.

Quture’s is exclusively engaged by HFACS, Inc. and its experts, Scott Shappell, PhD, and Doug Wiegmann, PhD, for investigation, analysis, classification and prevention interventions as the leading human factors experts internationally.  With their system embedded into QualOptima, Quture offers the proven and transformational system for medical device adverse events.