We have summarized the answers to some common questions, from which
you can obtain answers
01 Are your products medical device compliant? Yes. We are ISO 13485 certified, and most core products have CE0123/FDA clearance.
02 Consistency in high-volume production? Advanced automated lines, Class 10,000/100,000 cleanrooms, and MES monitoring ensure stable production.
03 Customization possible? Our in-house R&D supports full-spectrum customization from design to small-batch trials.
04 How is shelf-life ensured? Packaging is pressure- and microbe-tested; cold-chain logistics available for sensitive products.
05 Technical support? “Full-lifecycle” service: 24-hour response, remote guidance, on-site training, and clinical manuals.
06 Stable supply? Robust supply chain, long-term supplier agreements, and 3–6 months safety stock of key materials.
07 Documents available? Yes. Our RA team provides global regulatory-compliant technical files.
08 Complaint management? Strict adverse event monitoring per medical GXP standards.
09 Sample testing? Standard samples available for lab performance verification.