Trifanz Medical Passes EU CE On-Site Inspection

On August 17, the EU Notified Body Shanghai Intertek conducted a Unannounced Inspection to Trifanz Medical.

The auditors randomly selected laryngeal masks and endotracheal tubes with stylet and traced them back through the entire production process—including procurement, production, sterilization, testing, and inventory—to verify all records. The physical products, ledgers, and system data were all consistent, and the company successfully passed the audit with zero defects.

Since the new EU Medical Device Regulation (CE MDR, EU 2017/745) officially took effect on May 26, 2021, unannounced inspections have become a routine method of quality verification.

As a medical device company with a long history of operating in global markets, Trifanz Medical has successfully passed numerous authoritative international audits, including the EU CE MDR and the U.S. FDA, and has incorporated “full traceability and on-demand accessibility” into its daily management standards. For Trifanz Medical, unannounced inspections are not unexpected challenges, but rather another form of external validation of the day-to-day operation of its systems.

During this audit, following a brief meeting, the auditors proceeded directly to the warehouse to randomly select two products—laryngeal masks and endotracheal tubes with stylet —and reviewed the corresponding SOPs for raw material inspection and finished product inspection, as well as the inspection records and batch production records for LOT number. They also verified each stage of the process, including procurement, production, sterilization, inspection, and inventory. The physical inventory, ledgers, and system data were found to be fully consistent. The auditors paid particular attention to the inventory of endotracheal tubes with built-in guide wires, verifying on-site that the physical inventory, ledgers, and system data matched; the incoming material inspection data for laryngeal mask anti-reflux valves and indicator cuffs also matched the manufacturer’s reports exactly. The complete traceability chain from raw materials to finished products was fully covered, and for all sampled batches without exception, the physical inventory, records, and system data corresponded one-to-one.

“For us, unannounced inspections aren’t something that requires extra preparation—they’re a natural reflection of our day-to-day quality system,” said head of Trifanz’s QA department. “What matters most to us is whether every batch of products in our customers’ hands is just as reliable as what we saw on the day of the audit.”

Passing unannounced inspections is not the end goal, but rather the natural outcome of the system’s day-to-day operations. For distributors, this means lower factory audit costs and more stable supply expectations; for clinical users, it means that every laryngeal mask and every endotracheal tube—from raw materials to finished products—is subject to a strictly controlled and fully traceable system. Customers are choosing not just a batch of compliant products, but a system that consistently delivers safety. Every unannounced inspection serves as a testament to our daily commitment to quality.