With the continuous improvement of global medical standards and the popularization of ultrasonic diagnostic technology, there is a growing demand for high-quality medical ultrasound gels worldwide. To meet this global demand, manufacturers' production lines not only need to have sufficient capacity but also need to meet international standards to ensure that the products can meet the regulatory requirements and quality expectations of different countries and regions.
International standards are first reflected in the adherence to the quality management system. Pingchuang Medical's production line operates under the framework of the ISO 13485:2016 Medical Device Quality Management System, which is widely accepted and recognized globally. This means that its management processes, risk control, document records, traceability, and other aspects have reached international levels. This is the basis for its products to obtain authoritative certifications such as the US FDA and EU CE, and it is also the premise for meeting the standardized management requirements of global customers.
International standards have extremely high requirements for the production environment. The core production process of Pingchuang Medical's ultrasound gel is completed in a 100,000-class clean room. This standard meets and even exceeds the requirements of many countries for the production environment of non-sterile medical devices. The highly clean environment can minimize the risk of product contamination, ensure the purity and safety of the product, and meet the increasingly high demand of the global market for product hygiene standards.
International standards are also reflected in the production process and equipment level. Pingchuang Medical uses hygienic production equipment that meets GMP requirements, introduces advanced technologies such as vacuum homogenization emulsification, automatic filling, and online detection. The application of these technologies not only improves production efficiency but more importantly, it can accurately control process parameters, ensure the stability and consistency of product quality, and reach the level of international advanced technology. The degree of automation of the equipment also reduces the impact of human factors on product quality.
The international standard requires strict control over raw materials. Pingchuang Medical adheres to the selection of medical-grade raw materials that meet relevant standards and gives priority to suppliers and ingredients that are widely recognized globally and have a good safety record. Strict incoming material inspections ensure that the materials meet international quality standards (such as USP, EP pharmacopoeia standards, or corresponding ISO standards).
The international standard ultimately manifests in the compliance and quality of the product itself. The ultrasound gel produced by Pingchuang Medical meets the requirements of both the US FDA 510(k) and the EU CE certification, which means that the safety, performance, and labeling of its products have all undergone rigorous review by the two major mainstream markets globally. Strict finished product inspection procedures ensure that every batch of products leaving the factory meets the established international standards.
Pingchuang Medical has built production lines that meet international standards to better respond to global medical needs. Whether it is the stringent requirements of developed countries for high-quality and high-compliance products, or the demand of developing countries for safe, reliable, and cost-effective products, Pingchuang Medical can provide products that meet their standards. With experience serving 76 countries and regions globally, it has a deeper understanding of the differences in market needs and can provide corresponding solutions.
For medical device brands, distributors, and medical institutions worldwide, choosing a partner with an internationally standardized production line is crucial. With its adherence to international management systems, high-standard clean environments, advanced process equipment, strict control of raw material quality, and products that meet global mainstream certifications
