SaMD Quick Start Kit
The SaMD Quick Start Kit gives you the essentials to launch faster — basic training plus foundational FDA-starter templates to help you build compliance into your software from day one.
Regulation Ready
Comprehensive Program
Complete Solution
What's included?
Structured Program Framework
An agile approach to implement quality processes
Practical expertise that align with regulatory expectations
Starter Compliance Toolkit
Training + templates bundled for a fast, cost-effective launch
Built to reduce delays, errors, and FDA additional information requests
Basic Templates
Basic Design History File (DHF) templates
Starter documents, requirements, architecture, planning and more
Foundational Regulatory Training
Core SaMD regulatory requirements (FDA, IEC 62304, TIR45)
Step-by-step guidance on building compliance into your development process
Step-by-step guidance on building compliance into your development process
— Our limited time offer
SaMD Quick Start Kit
Kickstart your SaMD journey