CTI medical testing Laboratories certifies or tests a wide range of medical electrical and electronic equipment for different countries. With good professional knowledge on the requirement of (MDD) 93/42/EEC directive,(IVD) 98/79/EC , CTI medical team provide good product certification and testing advise to our customers according to IEC60601, ISO13485 Risk Management, ISO 14971 Medical device quality management systems, ISO/EN10993 Biocompatibility and Clinical validation.
In additional to FDA , FCC, UL and CE mark, CTI is familiar with china’s SFDA medical product certification process and can help our customers in getting their medical products to china markets within a short lead time interval.
CTI can provide testing for below medical equipment.
- All medical electrical equipment
- IVD equipment
- Alarm systems in medical electrical equipment and medical electrical systems
- High frequency surgical equipment
- Neuromuscular stimulation device
- Anesthetic systems
- Endoscopic equipment
- Automated non-invasive sphygmomanometers
- Blankets intended for heating in medical use
- Diagnostic ultrasonic device
- Hospital electric bed etc...
We also offer more service related to medical device industry:
Inspection service - for more details, please click here.
Audit service - for more details, please click here