To produce high-quality medical equipment and consumables, Visun has a professional factory in Bac Giang province, Vietnam. It is qualified by ISO13485 provides. Visun Medical manufacturing producing system meets the requirements of producers of medical equipment and consumables in environments where pharmaceutical goods and med-tech equipment are produced for a monitoring system that can deliver 100 percent testing. Our products are subject to the European Medical Device Directives. To legally market those products in Europe, they must undergo a conformity assessment procedure. Let’s discover our factory!
1. Outstanding manufacturing ability and the factory semi-automation
Visun owned the manufacturing factory in Bac Ninh province, Vietnam, which has 400 employees and daily producing over 3 million pcs each product. We surpass our competitors in high quality and service. With outstanding manufacturing ability thanks to applying factory automation, reliable testing procedures, and adequate production capacity, Visun could always guarantee perfect products and timely delivery to customers.
The factory semi-automation
Recent advances in the internet of things have resulted in an explosion of new products and applications for automation. And Visun does not stand out of this development trend when investing a huge automatic system into our production line. This brings us and our employees as well as customers many benefits. One of the best perks for the introduction of factory automation was improving workplace safety. Certain machining operations or assembly cannot be safely accomplished for a variety of reasons. Some manufacturing operations require operation at extreme temperatures or in the presence of dangerous chemicals. Other operations may require workers to handle or lift heavy or large parts or use hazardous tools. Semi-automation at Visun factory has the power to eliminate employees from hazardous situations.
Besides, there are some tasks that are difficult or nearly impossible to perform without the aid of a machine in order to adapt the sanitary conditions, especially in the industry of medical equipment and consumable that Visun is manufacturing which requires a strict process of sanitary conditions. Semi-automation assists our labors to work more effectively.
Huge number of workers
Making medical equipment and consumables are not as simple as it may seem. It is particularly challenging, even though we have helped by automation. More than 30 engineers, designers, and nearly 400 members of the manufacturing team were asked to work with product development, sourcing materials, and equipment as well as planning the production process. With that huge number of team members and workers, we can adapt a high capacity daily which is more than 3 million pcs for each product to serve the high needs of clients, especially in the COVID-19 pandemic.
3. Production Procedures: A process monitoring system with FDA- and MDR-compliant functionalities
At Visun, we invest the process monitoring system, in strict compliance with the guidelines of the FDA (U.S. Food and Drug Administration) and the MDR (Medical Device Reporting regulations). Therefore, the functions integrated into our producing system comply with the regulatory requirements for applications in the med-tech industry.
The system hardware meets the specific requirements for measurement equipment that apply in the med-tech industry as well, which includes:
– Design to accommodate exceptionally small measuring ranges (force-displacement -monitoring, torque sensor technology)
– Integrated management compliant with FDA regulatory requirements
– Audit trail: recording and monitoring of all changes to testing processes, with time and indexing for end-to-end traceability of each individual product
– Optional blocking of ports for secure integration into data structure
Some of the processes use repurposed materials and machines that the automaker utilizes in auto production, which include the material from an insulation supplier, a line-feeding and cutting machine, and scanners used for quality control. Hence, production processes are optimized. Thanks to the semi-automation system which visualizes process profiles and offers an extensive range of interfaces for connecting sensors. The system is integrated into the production line directly to monitor and evaluate the quality of any given manufacturing step – and therefore of the whole product on the basis of a curve. With the help of evaluation objects (EOs), workers can adapt the curve evaluation to the specific monitoring task.
3. Conforming to International Standards
Our Visun medical equipment and consumables manufacturing process conforms to the strictest of standards. Our factory with high quality and professional production line and all comply with CE, TUV, UL. We also comply with the international standard for medical device manufacturers which is ISO 13485:2012, which sets standards regarding both product quality and compliance with governmental regulations. Above earning this certification, we have consistently met both regulatory and customer requirements.
4. Packaging under a closed process
The final stage of the medical equipment and consumables manufacturing process is the packaging of the products. The most factor to consider in packaging our product is the sterile condition of the medical equipment and consumables. We use an automatic medical face mask packing machine system. It has a flexible adjustment system and a wide range of packaging. We also use hot melt glue box packing machine and mechanical brush glue box packing machine according to clients’ requirements. Appropriate steps are always taken to ensure both the initial sterile state of the device and the protection of that state during transportation.
We are proud that Visun Medical is constantly expanding business scale thanks to the establishment and launching of medical equipment and consumable production factories with the world-class med-tech process, producing products that meet all standards to be exported to strict markets. Come and discover our outstanding factory if you have a chance!