|
The bio-medical product regulation service section (Abbr. BPRS) in ETC is a professional crew which can provide the delicate service about medical device regulation issue, mainly including the safety/performance testing and quality management survey. Our testing lab is accredited by TAF according to ISO 17025 (No. 0371).
The practical services items including:
1. The type testing of medical electrical devices, according to IEC/EN/UL 60601-1 and related series standards. (Medical power supplier, display for medical purpose, electrical hospital bed, air mattress, powered suction devices, medical heating mattress, body fat scale, TENS, NIBP monitor, SPO2 monitor, blood sugar monitoring system)
2. The type testing of in-vitro diagnostic devices (according to IEC/EN 61010-1+IEC 61010-2-10) (Blood glucose meter, fluorescent immuno-analyzer,)
3. The surveying service for medical electrical equipment software V&V, helping the manufacturer to comply with 510K software V&V summary report (according to Guidance No.337)
4. The FDA 510K pre-market notification.
5. The integral technical and testing services of IEC 14971 and IEC 60601-1 3rd.
6. The routine verification testing for Clinical equipment such as NIBP, Defibrillator, SPO2 monitor, IV pump, HF-surgical instrument, etc.
7. The Taiwan medical devices GMP audit (designated by DOH, Taiwan).
 
NIBP performance testing Test facility for platform and side rail
of rlectrical hospital bed.
Contact us at:
Chang Shih-Ming, section manager
Mail: malta@etc.org.tw
Tel:+886-3-3280026 ext 512
Miss Hilda Hsieh
Mail: hilda@etc.org.tw
Tel:+886-3-3280026 ext 513
Mr. Andre Pan
Mail: Andre@etc.org.tw
Tel:+886-3-3280026 ext 629
| 
