Address
6F.-3, No.371, Sec. 1, Guangfu Rd., East Dist., Hsinchu City 30074, Taiwan (R.O.C.)
Contact
Tel：+886-3-666-0139
Fax：+886-3-666-0149
Email: services@seqpro.com.tw
Completed Regulatory Consultation Projects
| Medical Device Type | Related Consultation Package |
|---|---|
| Wearable Vital Sign Monitoring Device | Preclinical Safety Evaluation, Safety and Performance Evaluation, POC Clinical Trial approved |
| Personal Health Management Electronic Medical Device | ISO13485:2003 certified, TFDA GMP certified, TFDA medical permit granted |
| Assembly of Controller for Implantable Neural Spinal Stimulator | ISO13485:2003 certified |
| Assembly and SMT Processing for Blood Glucose Meter | ISO13485:2003 certified |
| Therapeutic Electronic Medical Devices (SPO2 Measuring Device) | 510(k) cleared, FDA presub |
| Intramedullary Surgical Device (Arthroscope) | 510(k) cleared, CFDA product designation and software V & VT for premarket registration, ISO13485/QSR/GMP Consultation |
| Spinal Implant Devices | Regulatory Pathways Analyses, Safety and Performance Evaluation, 510(k) Consultation, FDA Presub |
| Wound Dressing and Medical Consummables | Gap Analyses of QMS, ISO13485/QSR/GMP Regulatory Training, Quality Improvement, Safety and Performance Evaluation |
| Cardiovascular therapeutic device (LVAD) | Regulatory Pathways Analyses, ISO13485/QSR/GMP Regulatory Training, Safety and Performance Evaluation |
| Endometriosis IVD Screening Test | Gap Analysis of QMS, Clinical Evaluation, ISO13485:2016 and IVDD CE consultation |
| Color Fundus Diagnostic Software (Artificial Intellegance /Machine Learning based) | ISO13485:2016 certified, HSA registration granted |
| 3D-Printed Orthopedic Implantable Device | FDA Device MAF Filing, Safety and Performance Evaluation, 510(k) Consultation, FDA Presub |
| Real-time PCR platform and IVD reagents | Regulatory Pathways Analyses, ISO13485/QSR/GMP Regulatory Training, Safety and Performance Evaluation, IVDD CE consultation |
| Circulating Tumor Cell Screening System (Software and Assay Kit) | Regulatory Pathways Analyses, ISO13485/QSR/GMP Regulatory Training, Safety and Performance Evaluation, Medical CE Certification, 510(k) Consultation |
| Hyaluronic Acid based Filler (TFDA Class III product) | TFDA Product Registration permits granted |
| Resuscitator and Accessories | IEC62366-1:2015, IEC62366-2:2016 Training, Usability Evaluation |
| NIBP with new cardiovascular stiffness indices | Safety and Performance Evaluation (Software VVT, Usability Evaluation, etc.), Development of Clinical Pilot Study Protocol, Clinical Evaluation based on Meddev 2.7.1, de Novo 510(k) consultation, FDA Presub |
| Ultrasound and Medical Panel | 510(k) cleared, US Regulations & QSR Training, Consultation on QMS Enhancement |
| GMP/GDP of Local Branch Office | Gap Analyses of QMS, Quality Improvement, Safety and Performance Evaluation, TFDA GMP certified |
| Medical Tubing, Infusion Pump Accessories, Disposable Injection Needle (Urology) | Supplier Audit based on ISO13485/QSR/GMP/CMDCAS |