輔導經驗

項目	產品
CE MDD/ MDR 品質管理系統	• ENT Surgical Sponge • Dental Implants • Respiratory Care Medical Products • High-intensity focused ultrasound (HIFU) • Weighing Scales • Contact Lenses...
CE MDD/ MDR 技術文件/臨床評估	Class I • Acne Patch • ENT Surgical Sponge • Hydrocolloid Dressing • Electric Medical Bed • Mobility Scooters… Class IIa, IIb • Minimally Invasive Devices • Closed Suction System • Tracheostomy Tube • Heated Wire Circuit • Respiratory Humidifier • CPAP Mask • NIV Mask • BiPAP • Negative Pressure Wound Therapy (NPWT) • High-intensity focused ultrasound (HIFU) • Medical Electrical Air Cushion • Far Infrared Illuminator • Contact Lenses • ECG System • Dental Handpieces and accessories • Dental Implants • Powered Traction Equipment • TENS/EMS • Bone filling container • Percutaneous Discectomy kit… Class III • Radial Compression Device • Hemostatic Gauze • Balloon Dilatation Catheter • Hip Implant • Knee Implant...
FDA 510 (k)	• Class II (BZE) - Heated Wire Circuit • Class II (FYA) - Surgical Gown • Class II (BTT) - Humidification Chamber • Class II (NYV) - Gastrointestinal Motility System, Capsule • Class II (FYA) - Surgical Gown • Class II (NQQ) - Imaging System • Class II (NXC) - Clear Aligner
TFDA QMS / ISO 13485	• Syringe • Power Supply • PCR test equipment • High-Pressure Steam Sterilizer
臨床試驗	• Negative Pressure Wound Therapy (NPWT) • Ophthalmic Laser • Dental Implants • MRgHIFU
人因工程 / 可用性測試	• Ophthalmic Laser • Diabetes care App and Patient Management Platform • Hand diagnostic radiography imaging system • 3D virtual surgical tracking system for percutaneous radiofrequency ablation (RFA) • Electronic Stethoscope • Dental Implants • Large Volume Infusion Pump
其他	• Urine output recording system • Surgical Gown • Respiratory Humidifier • Breathing Frequency Monitor • Powered muscle stimulator...