CE and UKCA readiness
Evidence questions to answer before formal review
CE and UKCA planning starts with clarity: intended purpose, software role, connectivity, users, data handled, clinical context, and how the product will be maintained after launch.
Early questions
- What is the intended medical purpose and what software functions support it?
- Which assets, interfaces, data flows, and external services affect security or privacy?
- How do cybersecurity controls connect to safety risk management and usability engineering?
- What evidence proves updates, vulnerability monitoring, and post-market response are controlled?
- Which supplier components need security posture evidence or SBOM traceability?
The useful output is not a generic checklist. It is a traceable evidence model that shows why a control exists,
what risk it reduces, and which artifact proves it.
Where VigilySys fits
VigilySys organizes the evidence model across cybersecurity, privacy, and usability so founders can discuss readiness with advisors, partners, and reviewers from a single structured view.