ISO 13485 quality system
Covers design, development, production and distribution for rapid IVD reagents.
Trust Center
Documented quality systems behind every rapid test batch
IVD buyers need more than a good sample. They review certificates, validation evidence, batch records, production controls and post-market response. This page brings those trust signals together.
ISO 13485 certified
CE / market access documents
Patents and high-tech enterprise
GMP compliance audit package
ISO
13485
QC
Batch
CAPA
Closed loop
System and product certifications
A consolidated view of quality-system certificates, market access documents and intellectual property for distributors, registration consultants and OEM customers.
CE / DoC market access
CE declaration, EC representative registration and free-sale type documents can support different market reviews.
Core invention patents
Patent portfolio around colloidal-gold testing, strip cutting equipment and test-strip storage technologies.
High-tech enterprise
Evidence of sustained R&D investment, technology conversion and intellectual property capability.
GMP compliance: production-quality review files, site-audit checklist, equipment cleaning records, operator training records and batch documentation can be organized for customer audit review.
R&D and production capability
Clean laboratory scenes, standardized workstations and batch production environments support the path from validation to stable delivery.
01
Controlled clean laboratory
For antigen/antibody screening, sample handling, method optimization and validation.
02
Automation and standard workstations
Dispensing, cutting, assembly, packaging and inspection follow documented work instructions.
03
R&D and customer co-creation
Supports OEM/ODM formula, packaging, IFU and registration document collaboration.
Quality control and supply chain
Control points are embedded from raw-material lot intake to finished-product retention samples to help maintain intra-batch and inter-batch consistency.
1
Supplier approval
2
Raw-material lot inspection
3
In-process control
4
Finished-product release
5
Retention and traceability
6
Feedback / CAPA
Raw material control
Lot identity, storage condition, supplier qualification and incoming inspection records.
Batch consistency
Positive/negative reference samples, sensitivity, specificity, repeatability and line clarity.
Traceability
Batch record, COA, retained samples, customer feedback and CAPA closure.
Quality Journey
A quality system is not only a certificate on the wall. It is the traceable route every batch must pass through.
1
Raw material intake
Supplier approval, incoming inspection, lot number and storage conditions.
2
Antigen/antibody screening
Sensitivity, specificity, cross-reactivity and pair stability.
3
Uncut sheet production
Environmental control, dispensing/spraying/lamination process and intra-batch consistency.
4
Cutting / assembly
Equipment checks, operator station, in-process inspection and package integrity.
5
Intra/inter-batch QC
Positive/negative samples, sensitivity, specificity and repeatability.
6
Stability
Real-time stability, accelerated stability and transport simulation.
7
Finished release
Batch record, COA, labeling/IFU and visual inspection.
8
Retention sample
Retention ID, storage condition and traceability record.
9
Feedback / CAPA
Complaint handling, CAPA, recall readiness and field correction mechanism.
Partners and global delivery
Long-term support for brand owners, distributors, registration partners and laboratories through OEM/ODM, raw materials, uncut sheets and finished rapid tests.
- Brand-owner OEM/ODM customers
- Regional distributors and registration partners
- Third-party laboratories and clinical channels
- Veterinary hospitals and livestock end users
- Shipping coverage across Asia, Europe, Middle East, Africa and Latin America
60+
Markets
OEM
Private label
IVD
Rapid tests
QC
Documented
Need audit documents or a supplier questionnaire?
We can prepare ISO 13485, CE/DoC, FSC, technical files, performance evidence and production-quality questionnaires by target market and product line.
Request audit documents