SaMD Development, Verification & Validation
We support SaMD companies with development planning, lifecycle controls, verification, validation, AI/ML readiness, cybersecurity, and submission-ready regulatory documentation.
Building Clinical Evidence Across the Device Lifecycle
We support SaMD companies with structured development, lifecycle controls, verification, validation, AI/ML readiness, cybersecurity, and regulatory documentation for global submissions.
SaMD readiness begins well before verification and validation. Our approach supports the full software journey - from development planning and lifecycle controls to validation, cybersecurity, and submission readiness.
We help teams establish requirements, architecture, traceability, risk controls, and software lifecycle processes aligned to regulatory expectations. From there, we support verification and validation planning, clinical and analytical performance readiness, AI/ML evaluation, cybersecurity assurance, and the documentation needed for global regulatory pathways.
By connecting development, evidence generation, and regulatory documentation in one structured workflow, we help manufacturers build SaMD products that are technically sound, defensible, and ready for review.
Core Elements
Development Planning
Define intended use, requirements, architecture, and lifecycle strategy.
Lifecycle Controls
Establish traceability, risk controls, and software process discipline.
Verification & Validation
Build and execute structured V&V aligned to product claims and use.
AI/ML & Cybersecurity
Support model readiness, performance assurance, and security expectations.
Regulatory Documentation
Prepare submission-ready evidence and software documentation.
We support SaMD companies across development planning, lifecycle controls, verification, validation, AI/ML readiness, cybersecurity, and submission-ready regulatory documentation.
From SaMD Development to Regulatory Submission
A structured lifecycle covering development planning, software lifecycle controls, verification, validation, AI/ML readiness, cybersecurity, and submission-ready regulatory documentation.
Product Definition
Define intended use, claims, user needs, safety classification, and the development roadmap.
Development & Controls
Establish requirements, architecture, risk controls, traceability, and lifecycle documentation.
Verification & Validation
Execute structured V&V to demonstrate performance against intended use and defined requirements.
AI/ML & Cybersecurity
Address model validation, performance assurance, secure design, and cybersecurity readiness.
Regulatory Documentation
Build the technical documentation, evidence package, and validation summaries for submission.
Submission Support
Support authority review, response management, and approval readiness across global pathways.
Technology Stack & Regulatory Standards for SaMD
Our SaMD programs combine modern software engineering, AI/ML capabilities, data workflows, validation frameworks, and standards-aligned regulatory practices to support development, verification, validation, and submission readiness.
Built for AI-Enabled SaMD Development and Regulatory Readiness
We combine deep experience in AI-enabled software development, verification and validation, and standards-aligned regulatory execution to help manufacturers build SaMD products that are technically robust, clinically credible, and ready for global review.
AI-Enabled Product Expertise
We bring hands-on experience in developing AI-based healthcare solutions, including intelligent workflows, advanced analytics, and data-driven software products designed for regulated environments.
Verification & Validation Discipline
Our teams support structured verification and validation across software requirements, traceability, functional performance, risk controls, and intended-use evidence.
Standards & Compliance Alignment
We work with the standards and expectations that matter for SaMD, helping align development and documentation to applicable software lifecycle, risk management, usability, cybersecurity, and quality requirements.
Regulatory-Ready Development
We do not separate product development from regulatory readiness. We build software, evidence, and documentation together so the product is better prepared for submission and review.
AI/ML & Cybersecurity Readiness
We support model evaluation, performance monitoring, bias and change considerations, and cybersecurity controls needed for modern intelligent SaMD products.
End-to-End Delivery
From development planning and lifecycle controls through V&V and submission-ready documentation, we support the full SaMD journey in one connected framework.
Ready to Secure Your SaMD Approval?
From pilot code to final market clearance, our team delivers the evidence needed for global regulatory success.