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
Deep Learning and AI-Related Projects
2018 ~ Now
mdPCR System (including deep learning algorithm)
Achievements
- Setting up ISO13485:2016 QMS
- SW verification and validation implementation
- UI usability engineering implementation
Consultation Package
- ISO13485:2016 and ISO14971:2007
- IEC62304:2015
- IEC62366-1:2015
2018 ~ Now
Surgery Navigation System
Achievements
- Identification of FDA regulatory pathway
- Setting up ISO13485:2016 QMS
- Design control and risk management implementation
- SW verification and validation implementation
- UI usability engineering implementation
Consultation Package
- ISO13485:2016 and ISO14971:2007
- IEC62304:2015
- IEC62366-1:2015
- FDA 510(k)
- FDA Q Submission
2019
Ultrasound-guided Spinal Landmark Identification with Needle Navigation System
Achievements
- SW verification and validation planning
- UI usability engineering implementation
Consultation Package
- IEC62304:2015
- IEC62366-1:2015
2019
Optical Coherence Tomography Software (including deep learning algorithm)
Achievements
- ISO13485:2016 certification
- HSA product permit
Consultation Package
- ISO13485:2016 and ISO14971:2007
IEC62304:2015
2020
Clinical Flow Cytometry System (including deep learning algorithm)
Achievements
- Strategic planning for regulatory pathways
- SW verification and validation gap analyses & planning
- UI gap analysis and usability engineering planning
- Clinical evidence analysis and evaluation
Consultation Package
- IEC62304:2015
- IEC62366-1:2015
- Meddev 2.7.1 Rev. 4
- FDA Q submission
2018 ~ Now
Medical EEG Software (including deep learning algorithm)
Achievements
- Identification of FDA regulatory pathway
- Design control and risk management implementation
- SW verification and validation implementation
- UI usability engineering implementation
- Clinical evidence analysis and evaluation
Consultation Package
- ISO13485:2016 and ISO14971:2007
- IEC62304:2015
- IEC62366-1:2015
- Meddev 2.7.1 Rev. 4
- FDA Q Submission
2019
Brain Analysis Software (including deep learning algorithm)
Achievements
- Strategic planning for regulatory pathways
- SW verification and validation gap analyses & planning
- UI gap analysis and usability engineering planning
- Clinical evidence analysis and evaluation
Consultation Package
- IEC62304:2015
- IEC62366-1:2015
- Meddev 2.7.1 Rev. 4
- FDA Q submission