Software as Medical Device: Regulatory-Ready Development
FDA, CE, and international regulatory pathways require specialized expertise. We build SaMD with QMS, risk management, and design controls embedded—not bolted on after.
Software as Medical Device Defined
Software intended for medical purposes, without being part of a hardware medical device.
Medical Purpose
Intended for diagnosis, treatment, prevention, or monitoring of disease or medical conditions. The software itself is the medical device.
Diagnosis, treatment, monitoring
Platform Independent
Runs on general-purpose computing platforms—mobile devices, web browsers, cloud servers—not dedicated medical hardware.
Mobile, web, cloud
Regulatory Oversight
Subject to FDA regulation based on risk classification. May require 510(k), De Novo, or PMA clearance depending on intended use.
510(k), De Novo, PMA
Types of SaMD We Build
Diagnostic Software
AI-powered screening, image analysis, risk assessment algorithms that aid clinical diagnosis.
Monitoring Applications
Real-time vital sign monitoring, anomaly detection, alert systems for clinical intervention.
Therapeutic Software
Digital therapeutics (DTx) that deliver interventions for conditions like diabetes, mental health, chronic pain.
Informative Applications
Health data display, trend analysis, patient education tools that inform but don't diagnose.
Guardian Operating Room Monitoring
Real-time monitoring platform for OR environments with AI-powered anomaly detection, mobile alerts, and device integration—built with SaMD regulatory requirements from day one.
SaMD Compliance Requirements
ISO 13485
Quality Management System for medical device design and development
IEC 62304
Medical device software lifecycle processes
ISO 14971
Risk management for medical devices
IEC 62366
Usability engineering and human factors
Cybersecurity
FDA cybersecurity guidance and HIPAA requirements
Clinical Validation
Performance testing and clinical evidence requirements
Regulatory-Ready Development
Discovery
Determine risk classification, regulatory pathway, and user needs.
Regulatory strategy + risk class
Blueprint
Define requirements, initiate risk file, establish design controls.
Requirements + risk management file
Develop & Validate
IEC 62304 compliant development with verification and validation.
Design History File (DHF)
Submit & Maintain
FDA submission support, clearance, and post-market surveillance.
510(k) / De Novo + maintenance
We're not learning healthcare on your dime.
Calendar Year ROI. One team, concept to scale. 75-person integrated team.
Complete Value Chain
10 steps from messy data to measurable outcomes. Most AI projects fail at step 2—we deliver all 10 to production.
Verified Healthcare ROI
$10M+ PDPM recovery. $10M+ RAF improvement. Hard dollar returns within the calendar year.
Integrated Team
15 US architects + 60 nearshore delivery. Same timezone, HIPAA-compliant, partners not vendors.
"I have worked with many technology teams during my career, and Digital Scientists is one of the best. They take the time to understand the customers' needs, deliver innovative solutions, are always professional, and work with your team as a true partner to achieve success."
Amy Severino
Chief Innovation Officer, CommuniCare Health Services
Technologies
Ready to discuss your SaMD project?
30-minute call. No pitch. Just honest assessment of what's possible for your organization.
Or call: 404.654.3855
Regulatory Compliance & Data Security
SaMD requires both FDA compliance and data security. We build with HIPAA, FDA cybersecurity guidance, and international requirements (MDR, CE marking) from day one.
Learn more about our compliance approach →
