Skip to content

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

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