Faced with numerous water based lubricant OEM/ODM manufacturers in the market, brand owners often feel confused and unsure of how to choose. A reliable manufacturer not only concerns product quality and cost but also affects brand reputation and market expansion. A wrong choice may lead to product safety hazards, delivery delays, regulatory risks, and even cooperation disputes.
The primary consideration is the production qualifications and compliance. water based lubricants are regarded as medical devices or special cosmetics in many countries, and the production enterprises must have the corresponding qualification certifications. For example, in China, it requires the second-class medical device registration certificate, ISO 13485 medical device quality management system certification, as well as the US FDA 510K and EU CE certification for the international market. These certifications are the basis for the legal production and compliant listing of products. Pingchuang Medical Group has gathered these key certifications, indicating that its production system and products have reached the strict standards of mainstream domestic and international markets, providing solid compliance guarantees for customers.
The second factor is the production hardware conditions. A high-standard production environment is an important guarantee for product quality, especially purity and safety. It is crucial to examine whether the factory has a clean room and its cleanliness level (such as ten thousand-level). The overall scale of the factory, the age and automation level of the production equipment, also directly relate to production capacity, production efficiency, and quality stability. Pingchuang Medical has a modern production base of 16,000 square meters and a ten thousand-level dust-free workshop of 3,000 square meters, equipped with advanced production and testing equipment, and its hardware strength is in the leading position in the industry.
the completeness of the quality management system. Hardware alone is not enough; a rigorous and effective quality management system is the key to ensuring the continuous and stable production of qualified products. It should be understood whether the factory strictly implements GMP standards, whether there areperfectSOP (standard operating procedures), and whether there are strict checks and records from raw material inspection, process control to finished product release. Pingchuang Medical strictly follows GMP and ISO 13485 standards and has established a full-process quality management system to ensure that every link is under control.
the completeness of the service system. Cooperation is not just production, but also involves communication, design, regulatory support, logistics, and more. A reliable contract manufacturer should provide one-stop services, have a professional team responsible for coordination, be able to respond efficiently to customer needs, and solve problems encountered in cooperation. Pingchuang Medical provides comprehensive services from packaging design, regulatory consultation, qualification authorization to production and export logistics, committed to providing customers with a worry-free cooperation experience.
attention should be paid to the industry experience and market reputation of the enterprise. The brands and products that have been cooperated with, the export scope of the products, and the customer reviews can all reflect the strength and credibility of the enterprise from the side. Pingchuang Medical's products are sold to 76 countries, and it has established cooperative relationships with many well-known brands at home and abroad. Its rich industry experience and good market reputation are proof of its strength.