Seamless Implementation of Agile Methodologies
for SaMD with E2E Traceability

Your entire Medical Device & SaMD development process

Carefully designed by leading medical-tech professionals, this is the only place you need to come to for your business goals. Your medical device will get to the market through us quickly and grow steadily.


  • Robust and user-friendly document management to store everything in one place. And we have in-built digital signatures too!
  • Access hundreds of ready-made SOPs and templates across QMS, DHF and technical files – all compliant with medical industry standards
  • Navigate through a one stop boutique for QARA, including Design Control, Change Requests, CAPA, NC, Cyber Security, Clinical Evaluation, Training, Supplier Management and much much more

design change
  • Fully compliant design control for medical device and SaMD
  • Maintain a design and development file for each medical device
  • Generate records to demonstrate conformity
  • Records for design and development changes
  • Automatic tagging to the technical files
  • Automated technical file creation for the CE (MDR/UKCA), MDSAP and 510K submissions

  • Seamless implementation of Agile Methodologies for Software as a Medical Device development in compliance with IEC 62304.
  • Requirement (Backlog) Management, Design & Development sprint, Testing sprint, Defect fixing sprint, Risk management and Cybersecurity.
  • Ensure compliance with all relevant SaMD (Software as a Medical Device) and Medical Device design standards and guidelines with ready-made checklists, including: ISO 14971:2019 – Risk, IEC 62366 –
  • Usability, IEC 82304 – Product Validation, AAMI TIR-57 – Cyber Security, plus many more

Onboard seamlessly to S-Cube SmartEye with efficient admin screens

Benefit from the familiarity of MS Office tools embedded into S-Cube SmartEye’s interface

Take advantage of web grids for added bi-directional traceability, such as Requirements <-> Design <-> Risks or Requirements <-> Tests <-> Defects

Measure how your compliance process is progressing with customisable analytics dashboards

Access multiple projects across multiple users at any one time

Manage reviews and approvals in a clear and concise dashboard, with users notified instantly when a document is waiting for them to take a specific action

Import and export documents in a wide range of formats

Use a global navigator view to quickly get back to a project overview


Features for cross-team collaboration

Now you can manage individual users across departments and geographies. S-Cube SmartEye keeps your SaMD process streamlined and simple.

Features for audit readiness

S-Cube SmartEye takes the surprise out of audit inspections by ensuring your business is compliant on every aspect of SaMD and Medical Device design. This includes:

  • ISO 19011 compliance
  • Part 11 compliance
  • Internal Digital signatures
  • Inbuilt MS office to PDF conversion with data & time stamps

In world-leading company with Innovate UK

S-Cube SmartEye is proud to be sponsored by Innovate UK, a non-departmental public body funded by a grant-in-aid from the UK government.

This makes us a momentous project to impact the world of medical technology.

Want to find out more about how the features S-Cube SmartEye could revolutionise your business?

Contact Us