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Risk Management Articles & Analysis
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Imagine this: it’s 8:30 AM, and your hospital’s leadership team is preparing for a surprise Care Quality Commission (CQC) inspection. Despite weeks of effort, spreadsheets are scattered, incident reports are incomplete, and audit trails are missing links. The anxiety is palpable – because manual systems have left you vulnerable to compliance gaps. This is the reality for ...
Supplementary Services for Compliance and Development Efficient medical device development is not solely dependent on V&V. Services that offer risk management, quality management system support, and regulatory compliance assistance are essential. Protheragen-ING Lab provides these supplementary services to ensure that devices not only meet ...
Community Advocacy Groups: Organizations representing the interests of communities near hazardous waste sites use this information to understand the potential risks and advocate for proper cleanup and management practices. When Would HUMAN HEALTH RISK ASSESSMENT (HHRA) Information Be Used? ...
Caresyntax hosted a roundtable discussion on how digital transformation—specifically the collection of data in the surgical suite—can drive both quality and return on investment (ROI). The participants included a panel of esteemed healthcare professionals in surgery, nursing, investing, sales, healthcare technology, and academics. The following is a summary of the new pathways and ...
In recent years, there has been a growing trend of using video technology in surgical procedures to enhance precision, communication, and training. While the benefits of video in surgery are many, there are also concerns regarding the legal risks that may arise from its use. Medical professionals fear that video footage of a surgery could potentially be used against them in legal proceedings, ...
Mental health is a critical concern for all companies. One in five individuals will experience a mental health problem during their lives, according to the World Health Organization. For many people, the workplace is where mental health problems first begin and/or become exacerbated. ...
To assess potential CDMOs, certain criteria should be considered, such as how they identify critical project parameters, their past successes in overcoming challenges, and their approach to data analysis using a risk-based methodology. It is also important to evaluate if their experiments are purposeful and if their approach is scientifically sound and based on ...
They offer support for men at every step in the continuum of prostate cancer care, from understanding their risk to managing treatment side effects. Conor explained, “We have a simple ambition – to save and improve the lives of men affected by prostate cancer through funding research and supporting men and their families. We invest millions into ...
The EIR will be responsible for moving programs from inception through CM’s operational exit and beyond by defining strategy, engaging partners, guiding internal and external teams, managing timelines and budget, maintaining rigorous science, and managing risk. ...
As technology continues to advance software has become an important part of most products. It has become integrated widely into medical platforms. In 2019, the Software as a Medical Device (SaMD) market was estimated at about $18.4 million, and it is projected to reach $86 million by 2027 at an annual growth rate of 21.9%. As one of the fastest growing sectors in healthcare, we explore when ...
For patients and parents recently affected by or managing short bowel syndrome, TPN is likely new to their vocabulary. While any clinical acronym may sound overwhelming, TPN is not such a complicated one to understand. ...
SNP Array in Clinical Diagnosis Accurate identification and definition of genome aberrations can influence classifications of disease, patient risk stratification and clinical management options for a variety of genetic diseases, such as tumors. ...
Revisiting the “why” behind decision making can be a helpful exercise in all aspects of business. This is no less true for clinical operations executives when it comes to the clinical trial systems they employ to facilitate their teams’ work. The technology that supports clinical trial systems has evolved steadily over the past several decades, yet the ultimate goal of ...
Background Esophagectomy for cancer involves two- or three-phase procedures, such as abdominal, chest and/or neck incisions, is more invasive than other types of gastrointestinal surgery, and is associated with high risk for postoperative morbidity. Because of this risk, perioperative management of circulatory conditions such as hypovolemic ...
The experience provided an opportunity for us to look at construction quality management and how organizations can cope with social distance and the threat of a virus – not to mention the losses in capacity and operations resulting from them. By implementing better collaboration and innovation, the sector can recover from the impacts of the Coronavirus, operate more ...
These risk factors can easily lead to liver damage, which subsequently develops into liver fibrosis, cirrhosis and eventually liver cancer. ...
Healthcare provider organizations (HPOs) are starting to recognize the value of consolidating vendors and implementing an Enterprise Risk Management solution that is both holistic and comprehensive. But finding software – and a vendor – that can fulfill the promise of a true integrated solution for Enterprise Risk ...
It is an undeniable fact that safety and quality are the top-most priority for medical device companies. However, the best-practices to maintain these priorities are defined under ISO 13485. You cannot brush aside the need for implementing the right enterprise quality management software to create and maintain the culture of quality and continuous improvements. The software may help you meet ...
Governments can leverage collaborative decision making tools to better map complex, interrelated risk elements and ease data collection and synthesis; thus, improving the quality of the risk measures and development of strategic risk management alternatives. ...
Global manufacturers, among the hardest-hit by the COVID-19 pandemic, are looking for tangible ways to bolster resiliency – and for many that meant requesting a higher risk budget for 2021. Risk leaders are already investing 28 cents of every dollar for technology updates to help strengthen resilience. ...