Medical device refers to wide range of products right from diagnostic medical devices used in diagnosis of diseases, and abnormalities to therapeutic medical devices with applications including tissue cutting, wound covering, or closing open clogged arteries, to highly complex and mechanized medical equipment. Owing to their wide variety and critical importance for therapeutic treatment and care of the patient, it is increasingly important to regulate the manufacturing, functioning and distribution process to ensure their quality, safety, and efficient functioning. Medical device vigilance or materiovigilance, is the collection, evaluation, reporting, quality check and recognition of the condition of the devices resulting from their use. Medical device vigilance aims to protect the patients, healthcare facilities utilizing medical devices and others by preventing or reducing the occurrence of errors leading to harmful incidents and adverse effects. The detection of technical issues and potential adverse effects associated with medical devices is monitored by medical device vigilance. This post-market surveillance of medical devices was initiated by Food and Drug Administration with the enactment of the Modernization Act 1970 in the United States.
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COVID – 19 scenario analysis:
- The COVID-19 pandemic has emerged as a humanitarian as well as economic crisis, creating strain on the society and affecting millions of people and businesses
- Industry closures and people are asked to stay in their homes which has cause taken a huge toll in terms of money and economic growth
- Over 4 million people affected globally, with 300 thousand losing their lives due to SARS-CoV-2
- Healthcare organizations are already working in battle mode, preparing new plans to respond growing COVID-19 patients, right from sourcing rapid diagnosing kits to sufficient PPE kits for workers
- Due to diversion of medical field towards treating COVID-19, the funding to R&D activities related to medical device vigilance has been reduced and this segment have to face negligence subsequently causing negative impact on medical devices vigilance market
A myriad of factors such as growth in the number of medical devices recalls due to technical defects, increasing number of post market surveillance programs, rising incidences of adverse events related to faulty medical device, rise in the medical devices usage with increasing number of hospitals and adoption of medical device vigilance software are driving the growth of the medical device vigilance market. In April 2017, the South Korean regulatory authority Ministry of Food and Drug Safety (MFDS) launched ‘Harmful Medical Device Distribution Shutdown System’, a new recall system for medical devices. Furthermore, the rising tension on medical devices manufacturers to produce defect free devices as the patient lives are at stake, growing awareness among people pertaining to availability of medical device vigilance software and reporting of adverse events and stringent mandates of safety regulation post commercialization of medical devices by various regulatory authorities around the world such as U.S. FDA, Australian Therapeutic Goods Administration (TGA) and European Commission (EC) would potentially fuel the market growth. Thus, growing complexity and implementation of strict patient safety regulations is expected to amplify the growth of medical devices vigilance market.
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North American region expected to dominate the market
North American region is expected to grow due to factors like rising incidence of adverse events related to medical devices, recalls of medical devices due to safety issues as well as the presence key players in the market along with advancing paradigm of care is supporting the growth in this region. United States holds the largest market share due to factors such as high healthcare spending in the country and the availability of advanced healthcare infrastructure are few of the factors, which is anticipated to stimulate the growth for in-vitro colorectal cancer screening tests market in this region
Key segments covered:
Mode of Development
- Cloud-based
- On-premises
Applications
- Diagnostic Application
- Therapeutic Application
- Surgical Application
- Research Application
- Other Applications
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