Healthcare & Life Sciences

Why this matters

Saudi healthcare runs under a uniquely dense regulatory stack — MOH sets the digital-health policy, CBAHI audits the quality controls hospitals are accredited against, the SFDA regulates any software classified as a medical device, NPHIES is the national health-information exchange every claims and clinical-data pipeline now plugs into, and the SDAIA Personal Data Protection Law governs how patient data is stored, processed and shared. Build the platform wrong and any one of these can stall a launch for months. Mantiqi designs and ships hospital-grade EHR, triage AI, telemedicine and pharmacy integrations that are scoped against each authority on day one rather than retrofitted at UAT.

How we deliver

1. 01

   Regulatory scope + clinical workflow mapping

   Weeks 1–2

   We sit with clinical leadership and IT, map your existing patient journey, and classify which surfaces fall under the SFDA's medical-device software definition (anything that influences a clinical decision usually does). Output is a written compliance plan — MOH expectations, CBAHI controls touched, SFDA classification, NPHIES integration scope, SDAIA data residency.

   • Clinical workflow map (current + target state)
   • SFDA SaMD classification per surface
   • NPHIES integration scope (claims + clinical exchange)
   • Data residency + PHI handling plan
2. 02

   Secure platform build

   Weeks 3–10

   EHR / patient portal / triage AI / telemedicine surfaces ship in two-week iterations. HL7 FHIR-based NPHIES connectors land first because they're the riskiest. Arabic-first UX with RTL, mixed-language clinical free-text, and an evaluation harness for any AI surface so accuracy is measured rather than hoped for.

   • FHIR-based NPHIES connectors
   • Arabic + English clinical UI
   • Audit-grade encrypted PHI store
   • AI evaluation harness with held-out clinical sets
3. 03

   Clinical validation + CBAHI readiness

   Weeks 9–14

   Clinical pilot with named end-users, structured evaluation against the eval set, IT-security review against NCA ECC, and CBAHI control-mapping for the surfaces that touch accredited standards. SFDA submission support where the software classifies as a medical device.

   • Clinical pilot report + signed acceptance
   • Penetration test + remediation
   • CBAHI control mapping
   • SFDA submission package (when applicable)
4. 04

   Go-live + ongoing surveillance

   Ongoing

   Production monitoring with clinical-incident workflows, quarterly model refresh on any AI surface, annual NCA + SDAIA reviews, and post-market surveillance for SaMD-classified surfaces. We don't disappear at go-live — managed services keep the regulatory posture intact between audits.

   • Production monitoring + clinical incident workflow
   • Quarterly AI model + retrieval refresh
   • Annual NCA / SDAIA review support
   • Post-market surveillance dossier (SaMD)

Compliance & regulators we work with