Software as a Medical Device (SaMD)

The Problem We Solve

Software as a Medical Device is the fastest-growing segment in the global medical device market. But SaMD development carries distinct risks: AI models that cannot be validated under current FDA guidance, software architectures that fail IEC 62304 classification, and cloud platforms that do not meet HIPAA or DPDP requirements. We develop SaMD with regulatory compliance embedded into the software architecture from the first sprint.

What We Do

Four SaMD disciplines — built for regulatory clearance and clinical adoption simultaneously.

🤖 AI/ML-Enabled Diagnostic Software

Machine learning model design for diagnostic and monitoring applications
Training data strategy and clinical dataset curation
Algorithm validation against clinical benchmarks and reference standards
Explainability frameworks for regulatory submissions
FDA Predetermined Change Control Plan (PCCP) preparation

💻 IEC 62304 Software Lifecycle Compliance

Software classification (Class A, B, or C) and risk assessment
Software Development Plan and architecture documentation
Unit, integration, and system test framework development
Software requirements specification and traceability matrix
Anomaly resolution and software maintenance procedures

☁️ Connected Device & Cloud Platform Development

Device-to-cloud data pipeline architecture and security design
HL7 FHIR integration with hospital HIS and EMR systems
Real-time patient monitoring and clinical alerting dashboards
Secure cloud infrastructure compliant with HIPAA and India DPDP Act
Mobile application development for iOS and Android

🏥 Clinical Decision Support & Workflow Integration

Clinical decision support system (CDSS) development
Workflow integration with radiology, pathology, and ICU systems
Alert logic design with configurable clinical thresholds
User interface design aligned to IEC 62366 usability standards
Clinician-facing and patient-facing application variants

Who This Is For

We work with teams building software intelligence into healthcare — from first concept to regulatory clearance.

MedTech companies adding software intelligence to existing hardware devices

Digital health startups building AI-powered diagnostic or monitoring applications

Hospital groups developing proprietary clinical decision support tools

Companies with SaMD products that have received FDA or Notified Body software-related observations

Why 369 Innovations

We do not develop medical software as a general IT project. Every architecture decision, testing protocol, and documentation artifact is designed to withstand regulatory scrutiny — and to deliver measurable clinical utility. Those two requirements are not in tension. They reinforce each other.

Key Differentiator: SaMD built for regulatory clearance and clinical adoption — simultaneously.

Build SaMD That Regulators Accept and Clinicians Trust.