The North American market, as the core of the global high-end medical consumables market, has extremely high entry barriers for product quality, environmental friendliness, and compliance. The FDA green audit, in particular, is a comprehensive test of a company's production processes and environmental philosophy. To accurately meet the needs of the North American market, MAXIM MEDICAL and LABWARE CO., LTD assembled a dedicated R&D and compliance team, spending over a year iterating and upgrading its production processes. In blood collection tube production, biodegradable bio-based materials were used to replace traditional PET materials, ensuring product safety while reducing environmental burden. In microscope slide production, the formula was optimized to achieve impurity-free, high-transparency, and environmentally friendly products, fully complying with the FDA's green requirements for medical consumables.
Meanwhile, relying on eight automated cold forming production lines and six precision hot rolling systems, the company achieves precise control over product accuracy and stability. Each batch of products undergoes multiple processes, including sterility testing, precision calibration, and environmental indicator testing, ensuring that all data fully meet FDA review standards. Furthermore, the company's compliance team proactively reviewed North American medical device regulations and completed the entire process of product carbon footprint calculation and environmental certification, providing strong support for successfully passing the audit.
"Passing the FDA green audit is a significant milestone for MAXIM MEDICAL and LABWARE CO., LTD in expanding its North American market," said the company's foreign trade director. Several large North American medical device distributors have already proactively reached cooperation agreements with the company, and the first batch of green compliant products has been successfully shipped. In the future, the company will use this successful audit as an opportunity to further cultivate the North American market, continuously optimize the green attributes and performance of its products, provide North American medical institutions with higher-quality medical consumable solutions, and enhance the influence of Chinese medical consumable brands in the North American market.
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