Certification in medical devices is granted per model and per market, not once for a company. The list below is what AOJ Health publishes about itself; the model-level position for your market is confirmed on request and supported by the certificate file itself.
- 510(K)United States
- MDR CEEuropean Union
- NMPAChina
- ISO 13485Quality management
- BSCISocial compliance
- RoHSHazardous substances
- REACHChemical safety
- FSCPackaging
- FCCRadio frequency
Quality system
- ISO 13485 quality management system for medical devices
- Quality engineering across DQE, SQE, PQE, IQC, IPQC, OQC, FQC and QC
- 100% final inspection before packing
- Test reports supplied with production, on request
Design recognition
- iF Design Award — iF International Forum Design
- Good Design Award — Japan Institute of Design Promotion
- Red Dot Award — Red Dot
Is certification granted to the company or to each product?
To each product, in each market. A model cleared for the EU is not automatically cleared for the United States. We confirm the model-level position for your destination before quoting.
Can you handle registration for my market?
Yes. Registration and certification support is part of the ODM scope — the file work, the testing and the liaison with notified bodies or agents.
Will you send certificates and test reports?
Yes, for the specific models and markets in scope, once an NDA is in place. Write to marketing@aojmedical.com.