SaMD Regulatory Pathways & Software QMS

We support specialized software architectures across human diagnostic, therapeutic, and veterinary clinical domains.

CAD-Based Software

AI/ML Diagnostic Engines

Veterinary Medical SaMD

Computer-Aided Detection algorithms for radiological imaging, mammography, and tissue anomaly identification.

Adaptive and fixed machine learning models driving automated pathology scoring, ECG interpretation, and predictive triage.

Standalone software for animal diagnostic imaging, dosage formulation, and species-specific clinical monitoring.

Classifications and Standards

Healthcare Purpose & Situation

Software is categorized into Category I-IV based on state of healthcare (Critical, Serious, Non-serious) combined with clinical purpose: Treat/Diagnose, Drive Clinical Management, or Inform Clinical Management.

Applicable SaMD Standards

Full compliance mapping across IEC 62304 (Software Lifecycle), ISO 14971 (Risk Management), IEC 82304-1 (Health Software Safety), and IEEE 29119 software testing protocols.

SaMD QMS & Digital Health Requirements

Digital Health Privacy & DPDP

Full QMS Implementation & Auditing

Structuring healthcare software data architecture to comply with India Digital Personal Data Protection (DPDP) Act, HIPAA cloud hosting rules, and EHR interoperability.

Custom ISO 13485 quality systems tailored for software units: defect tracking, version control, change management, and verification & validation (V&V) master files.

Cybersecurity & Vulnerability Mgmt

Threat modeling, SBOM generation, patch governance, and penetration testing reports required for CDSCO and global health authority submissions.

Consult our regulatory engineers for CDSCO registration, IEC 62304 software documentation, and software quality management.