Software as a Medical Device (SAMD)
SAMD refers to software that performs medical functions without being part of a physical device. These software solutions help diagnose, monitor, and treat medical conditions through data analysis, often powered by AI or machine learning. SAMD must meet stringent regulatory requirements to ensure safety, reliability, and compliance with healthcare standards.
Key Features of Our SAMD Solutions
Our Software as a Medical Device (SAMD) solutions offer advanced features that enhance patient care. With a focus on compliance and performance, we ensure that our software meets the highest standards.
Real-Time Data Processing for Better Decisions
Experience immediate insights with our real-time data processing capabilities.
User-Friendly Interfaces for Enhanced Usability
Our intuitive interfaces ensure ease of use for healthcare professionals.
Seamless Integration with Existing Healthcare Systems
Our solutions integrate effortlessly with your current systems.
AI-Powered Diagnostics for Faster Patient Care
Leverage AI to enhance diagnostic accuracy and speed.
Ensuring Compliance in Medical Software Development
At 26bitz, we prioritize regulatory compliance in our Software as a Medical Device (SAMD) solutions. Our commitment ensures that healthcare providers can rely on our products for safe and effective patient care.
Regulatory Assurance
We adhere to FDA, CE, and global standards for medical software compliance.
Patient Safety
Our solutions enhance patient safety and provide accurate tools for healthcare professionals.
Guiding You Through Every Step of SAMD Development
Understanding Your Medical & Regulatory Needs
We start by diving deep into your SAMD’s purpose—whether it’s for diagnostics, monitoring, AI-driven decision support, or another medical function. We also map out the regulatory requirements, ensuring early alignment with FDA, MDR, ISO 13485, IEC 62304, HIPAA, or SOC 2 standards.
Risk Management & Compliance-First Design
SAMD development demands a risk-based approach. We integrate risk management from the start, ensuring your software adheres to ISO 14971 and other safety standards. Our UX/UI design also prioritizes usability engineering, essential for compliance and seamless adoption in clinical settings.
Architecture & Development Aligned with Standards
Unlike traditional software, SAMD must follow strict design controls and traceability. We ensure:
Compliant software architecture following IEC 62304 (software lifecycle processes)
Cybersecurity best practices to meet industry expectations (e.g., FDA's cybersecurity guidance)
AI/ML-specific validation if your SAMD involves machine learning models
Regulatory Submission & Market Entry Support
We assist with documentation for 510(k), De Novo, PMA, MDR CE marking, or other regulatory pathways, streamlining your approval process. Our team also helps prepare for regulatory audits and submissions.
Post-Market Surveillance & Ongoing Compliance
SAMD doesn’t end at launch. We support post-market monitoring, real-world performance tracking, cybersecurity updates, and regulatory compliance maintenance to ensure long-term safety and effectiveness.
Schedule a consultation with our team
Please provide a brief overview of your project and your earliest availability, and we will get back to you as soon as possible.