Quality & Certifications
Every Kangli implant and instrument is designed, manufactured, and released under a certified ISO 13485 quality management system — and verified against CE, FDA, and GMP requirements. This is the regulatory foundation our OEM, ODM, and OBM partners build on.
One ISO 13485 system, from design to dispatch
Kangli has manufactured orthopaedic implants and surgical instruments to formal quality standards since 2002. A single EN ISO 13485:2016 quality management system governs the full device lifecycle — design and development, manufacturing, sterilization, distribution, and post-market surveillance — so every locking plate, intramedullary nail, spinal system, and instrument set is traceable to the controls that produced it.
The same system underpins our OEM, ODM, and OBM programs. Partners inherit a documented, audited quality framework, with material certificates, process-validation records, and full lot traceability available on request for regulatory submissions.
Certifications & clearances
Open any card to preview the full certificate.
EN ISO 13485:2016
Medical-device quality management for the design, manufacture, and distribution of orthopaedic implants and surgical instruments.
View
CE — Full Quality Assurance
Full Quality Assurance System under the Medical Device Directive 93/42/EEC, Annex II. Our CE MDR certification is now actively in progress.
View
FDA 510(k) Clearance
510(k) premarket notification cleared for the KangLi Locking Plate System — Class II under 21 CFR 888.3030.
View
How conformity is assured
From incoming material to post-market surveillance, every device is held to documented, auditable controls — the same controls we open to partners and auditors.
Design controls & risk management
Design and development follows ISO 13485 design controls, with documented risk management maintained across every device family.
Material traceability
Only medical-grade titanium and stainless alloys to recognised ASTM / ISO standards — each heat certified and traceable to the finished lot.
In-process & final inspection
Dimensional and metrological verification at defined control points, with a documented final-release inspection before packaging.
Cleaning & sterilization validation
Validated cleaning, packaging, and sterilization processes for every product supplied sterile.
Full lot traceability
Each implant and instrument is traceable by lot from raw material to the customer, supporting recall readiness and complaint handling.
Audits & post-market surveillance
Periodic notified-body surveillance audits and active post-market surveillance keep the quality system current.
Verified from first billet to finished device
In-house verification at every critical stage.
Quality checks are built into the manufacturing process. Each material lot is identified, traceable, and verified before machining begins. Throughout production, components are inspected against defined requirements; semi-finished and finished devices then undergo mechanical and performance testing as applicable.
This end-to-end control means each released device is manufactured and verified to the same defined requirements.
Storage & traceability Automated storage carousels
Alloy stock is booked into automated vertical carousels and issued under system control — every bar identified, every movement logged, so lot traceability begins before the first cut.
Chemical composition Spark optical-emission spectrometer
Every incoming heat is burned and read element by element, confirming the alloy matches its certificate before material enters production.
Gas content Oxygen–nitrogen–hydrogen analyser
The same heat is measured for interstitial gas content — the levels that decide whether a titanium or stainless lot is fit for implant use.
Mechanical properties Electronic universal testing machine
Computer-controlled tensile, compression, and bend tests measure the mechanical performance of semi-finished and finished parts against specification before release.
Fatigue life Metal fatigue test system
Finished implants are cycled under simulated physiological load — confirming a plate or nail survives years of repeated use, not a single static pull.
Frequently asked questions
Answers on our quality system, certifications, and regulatory status.
Which quality management system does Kangli operate under?
What certifications and clearances does Kangli currently hold?
EN ISO 13485:2016 (TÜV Rheinland), a CE EC Certificate for a Full Quality Assurance System under Directive 93/42/EEC (Notified Body 0197), and FDA 510(k) clearance (K133840). Manufacturing is GMP-compliant. You can preview each certificate from the cards above.
What is the status of your CE MDR certification?
Our CE MDR application process has already started, and we are actively advancing it. Based on our established quality system, regulatory experience, and preparation progress, we are confident in obtaining approval soon. In the meantime, every device remains governed by our Full Quality Assurance System under Directive 93/42/EEC and our EN ISO 13485:2016 quality system.
Do Kangli implants have FDA clearance?
Yes. The KangLi Locking Plate System, a Class II device under 21 CFR 888.3030, holds FDA 510(k) premarket clearance (K133840). The clearance letter is available to preview from the certification cards above.
Can we obtain certificate copies and quality documentation for a regulatory submission?
Yes. Partners can request material certificates, process-validation records, and full lot traceability to support their own regulatory submissions. Certificate copies are available to preview on this page, and detailed quality documentation is shared under a mutual non-disclosure agreement.
What materials do you use, and how is traceability maintained?
Kangli uses only medical-grade titanium and stainless alloys to recognised ASTM / ISO standards. Each heat is certified, and every implant and instrument stays traceable by lot from raw material to the customer — supporting recall readiness and complaint handling.