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Drag and drop cards in the correct order to build the regulatory lifecycle
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The Regulatory Life Cycle for Medical Software
An Interactive Guide
Mini-Game
Start
Need
Idea
Device Class
Company
Company Breakdown
QMS
Setup
ISO Standards
Policies
Documents
EQMS
Traceability
Change Control
FDA/CE/UKCA
Tech File
Templates
Diagrams
Specify
Requirements
Risk
Design
External
Internal
Development
Design and Development
Code
IFU
Verify
Robotic
Human
Validate
Clinical
Technical
Submit
FDA/CE/UKCA
Rollout
Regulate and Maintain
Service Desk
Marketing
Sales
Maintain
Bug Fixes
New Features
Post-Market
Finish
Sale
Takeover
Finish
Start
Welcome to our interactive guide to the development lifecycle for creating a software medical device.
Start
Company
QMS
Tech File
Specify
Design
Dev
Verify
Validate
Submit
Rollout
Maintain
Finish
