What you will Learn
from Playbook
from Playbook
The Software as a Medical Device (SAMD) Playbook
The Software as a Medical Device
(SAMD) Playbook
Building Software as a Medical Device requires more than strong engineering. It demands clinical clarity, regulatory discipline, and evidence-backed execution. As SaMD continues to redefine digital health, founders, product leaders, and healthcare innovators must navigate complex regulatory frameworks while delivering measurable patient impact.
What this playbook is?
The Software as a Medical Device Playbook is a comprehensive guide designed for HealthTech teams building regulated medical software. It explains how to move from medical problem identification to market launch while maintaining compliance, safety, and clinical trust at every stage.
What it covers?
This playbook covers how SaMD products are defined, classified, designed, validated, launched, and scaled across global regulatory environments including the FDA and EU MDR. It also introduces practical frameworks such as Medical Problem Identification, Clinical Problem Definition, Minimum Product Increment planning, and lifecycle-based execution models used by leading SaMD teams.
What it covers?
Whether you are building diagnostic software, digital therapeutics, AI-driven clinical tools, or remote patient monitoring platforms, this guide provides a clear and actionable path forward.
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