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Software as a Medical Device (SaMD)

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Navigating SaMD Compliance in a Rapidly Evolving Landscape

Syrma Johari MedTech supports this through end-to-end SaMD regulatory and engineering services, including software lifecycle compliance, clinical and technical documentation, cybersecurity risk assessment, and submission support. With integrated QARA and engineering expertise, SJML helps OEMs develop compliant, secure, and scalable digital health solutions.

End-to-End SaMD Regulatory & Quality Capabilities

  • SaMD classification and pathway definition  
  • Global regulatory strategy (FDA, EU MDR, IMDRF)  
  • Intended use and claims alignment  
  • SDLC framework design and implementation  
  • Design controls and traceability (URS → V&V)  
  • Integration with QMS processes  
  • ISO 14971 risk management integration  
  • Clinical evaluation and performance validation  
  • Benefit-risk documentation 
  • DHF, DMR, Technical File development  
  • Verification & validation documentation  
  • Audit-ready submission packages  
  • Secure architecture and threat modeling  
  • Software cybersecurity risk management  
  • AI/ML compliance (GMLP, EU AI Act considerations)  
  • Post-release vulnerability monitoring  
  • PMS planning and documentation  
  • Change management for software updates  
  • Real-world performance monitoring  

Accelerate Your SaMD Compliance Journey

Partner with SJML to build compliant, scalable, and audit-ready digital health solutions.

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