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IEC 62304 & Cybersecurity
SaMD, Software, AI & Cybersecurity (SFDA)
Software Regulatory Strategy Begins With the Medical Function. Software may itself meet the medical-device definition or may form part of a hardware medical device. The Saudi strategy should therefore begin with intended medical purpose, software functionality and risk before deciding classification and evidence requirements.
When This Support Is Needed
Standalone software (SaMD), mobile medical app, or cloud-based clinical platform entering Saudi Arabia
Incorporating Artificial Intelligence (AI) or Machine Learning (ML) algorithms for diagnostic or predictive purposes
Releasing a significant software update, algorithmic revision, or cybersecurity firmware patch
Compiling cybersecurity risk management documentation and Software Bill of Materials (SBOM) for SFDA review
What We Challenge Before Submission
Does the software provide medical decision support that qualifies it as a regulated medical device?
Is the software risk class commensurate with the severity of clinical impact resulting from an erroneous output?
Are all software system requirements bidirectionally traceable to verification test cases and risk controls?
Is the released software build version accurately documented across application forms and technical files?
Could an ongoing AI model retraining pipeline trigger a mandatory regulatory variation with SFDA?
Our Software & AI Regulatory Scope
SaMD qualification and medical device regulatory status determination under SFDA guidelines
Intended clinical purpose, algorithmic outputs, and clinical marketing claims review
Software risk classification strategy based on IMDRF framework and SFDA rules
IEC 62304 software lifecycle documentation compilation (architecture, unit, integration, system testing)
Software architecture diagrams, data-flow models, and external interface descriptions
Software of Unknown Provenance (SOUP) and third-party library vulnerability management
Software hazard analysis and risk management under ISO 14971
Software verification and validation (V&V) test report authoring and traceability matrix
Cybersecurity risk management file, threat modelling, and vulnerability penetration evidence
Clinical performance validation for software-driven diagnostic or treatment recommendations
AI/ML algorithmic transparency, training data provenance, and change-control protocols
GHAD portal submission, bilingual Arabic/English e-IFU alignment, and software version tracking
Post-market software defect tracking, patch management, and vigilance procedures
Integrated Review Strategy:
We do not review software documentation in isolation. We connect the medical function, classification, failure modes, cybersecurity risks, validation evidence and claims to the Saudi authorization pathway.
Authorize Your SaMD and AI Health Software with SFDA
Our digital health regulatory engineers prepare IEC 62304 lifecycles, cybersecurity risk documentation, and MDMA submissions.