The expansion of the medical device vigilance market is anticipated to be driven by an increase in the launches of recall systems for medical devices.One of the key factors fueling the market's expansion is the rising number of recall systems. For instance, the South Korean Ministry of Food and Drug Safety (MFDS) introduced a new recall procedure for medical devices in April 2017 called the "Harmful Medical Device Distribution Shutdown System." Thermometers, pregnancy test kits, and electronic blood pressure monitors are a few medical items that have been recalled as a result of this system. Furthermore, the market for medical device vigilance is anticipated to increase as there are a rising number of post-market monitoring programs for medical devices. For instance, Lombard Medical, Inc. began a post-market surveillance program for Aorfix in April 2015. For the treatment of individuals with aortic neck angulations up to 90 degrees, aorfix is a medical device. A growing number of national registers for medical implant devices in North America is predicted to provide this area the highest market share in the medical device vigilance sector. For instance, the National Medical Registry for Medical Implant Devices was introduced by The Veterans Affairs in June 2018.
According to Coherent Market Insights, The market for Medical Device Vigilance was valued at US$ 53.4 billion in 2018 and is anticipated to grow at a CAGR of 8.1% from 2019 to 2026.
Key Companies in the Medical Device Vigilance Industry:
1. ZEINCRO
The company was started in 1998 and is based in Sofia, Grad Sofiya, and Bulgaria. A contract research organization (CRO), ZEINCRO offers its services to more than 21 European nations, with a strong emphasis on the Central and South-Eastern European region. ZEINCRO is a company that offers its services as a contract research organization.
2. AssurX, Inc.
The company was founded in 1993 and is based in Morgan Hill, California, United States. IT software services are offered by Assurx, Inc. The business provides prepackaged software together with technical support, professional development opportunities, and training, integration, and installation services.
3. Sparta Systems
The firm was started in 1994 and is located in Holmdel, New Jersey, United States. The life sciences sector uses enterprise quality management software (QMS) from Sparta Systems, which also offers a cutting-edge SaaS platform.For the pharmaceutical, medical device, and consumer goods industries, Sparta Systems ("Sparta") is the top supplier of quality management software.
4. Oracle Corporation
The firm was founded in 1977 and is located in Austin, Texas, U.S. The business provides enterprise business applications, decision support tools, databases, and relational servers for use in application development. The acquisition of Cerner, a provider of health information technology, by Oracle was announced on December 20, 2021. Oracle declared on March 31, 2020, that it has signed a contract to buy LiveData Utilities.
5. Xybion Corporation,
The firm was started in 1977 and is based in New Jersey, United States. The Corporation is a provider of digital software platforms and a consulting firm. The company's primary goal is to assist businesses in finding solutions to their issues while developing new capabilities in sectors that are subject to regulation. Xybion announced in February 2023 that it would demonstrate Labwise XD at the SmartLab Exchange in Del Mar, San Diego, California.
6. Sarjen Systems Pvt. Ltd.
The business was founded in 1998 and is based in Ahmedabad, Gujarat, India. In a number of different sector categories, including pharmaceutical, healthcare, and others, Sarjen offers business and GxP compliance software solutions and services. Sarjen makes ongoing investments in acquiring cutting-edge technology in order to develop original solutions.
7. Omnify Software, Inc.
The business was started in 2002 and is based in Tewksbury, Massachusetts, United States. Pre-packaged computer software design, development, and production are all part of the company's business activities. Product life cycle management (PLM) solutions are offered by Omnify Software, and they are simple to set up and use.
*Definition: Medical device vigilance involves event reporting, adverse reactions, post-market surveillance, and recalls of medical equipment. By lowering recurrences of incidents connected to the use of medical devices, medical device vigilance primarily aims to improve patient health and safety.
