Free UK education on SaMD regulation and clinical safety for digital mental health
From the Intended Purpose Battlefield to ISO 14971, AAMI TIR34971 and NHS DTAC. Practical modules for founders, clinical leads and regulatory advisors who need to get MHRA classification and clinical safety right.
Last reviewed: June 2026 · Next planned review: September 2026
MHRA Certification Pathways
Interactive guide to Class I, IIa, IIb and III SaMD certification: timeline, cost, Approved Body requirements and ownership across each phase.
Start module →MHRA Classification Self-Study Guide
UK regulatory context. 16 primary sources, standards and guidance documents, sequenced across four phases. Track your progress as you read.
Start module →Ten advanced advisory modules
The hardest UK judgement calls in DMHT classification: medical purpose, functionality forensics, multi-modular architecture, competitor audits, ISO 13485, ISO 14971, AAMI TIR34971, the NHS DTAC procurement gate, and assigning likelihood, severity and risk. With interactive exercises.
Open modules →About the Academy
The F&G Strategy Academy is a free educational resource. Progress through the study guide is saved locally on your device. These materials are provided for informational purposes and do not constitute formal regulatory or legal advice. Content is reviewed every 3 months.