01
Pre-validated platform
Deploy on a GAMP 5 Category 4 validated platform with IQ/OQ protocols, validation summary reports, and ongoing change control documentation.
Regulated discrete · Platform Module
A validated digital backbone for 21 CFR Part 820 compliance.
Medical device quality systems demand validated software, controlled documents, and complete traceability. Dynamism Factory provides the platform layer that enforces these requirements across every workflow without slowing production down.
Capabilities
What the Platform module does for Medical Devices.
Centralized compliance, traceability, and governance across every workflow.
02
Electronic signature compliance
21 CFR Part 11 compliant electronic signatures with meaning, timestamp, and signer identification for every approval and sign-off.
03
Training management
Track operator training, competency assessments, and certification expiry with automatic production access restrictions for unqualified personnel.
04
Design history file assembly
Automatically compile design inputs, outputs, verification, and validation records into a structured DHF as development progresses.
Why it matters
Where Medical Devices teams get stuck.
These problems look operational on the surface, but they are usually coordination and information problems underneath.
01
Computer system validation (CSV) for each manufacturing tool takes months and costs six figures.
02
Document control systems are disconnected from the shop floor, creating revision mismatches.
03
Training records must prove competency before operators touch product, but tracking is manual.
04
Design history files (DHF) are assembled manually at the end of development, missing critical records.
Use cases
How teams use Platform in Medical Devices.
Real workflows that connect the module to the problems above.
01
New product introduction
Launch a new device with automatic DHF compilation, process validation tracking, and training deployment to production operators.
02
Supplier qualification management
Manage approved supplier lists, supplier audits, and incoming inspection requirements with automatic enforcement at receiving.
03
Management review data package
Generate the complete management review data package including CAPA metrics, complaint trends, audit findings, and process performance data.
Explore further
Related pages.
American Dynamism
Better Platform for American Medical Devices manufacturers starts here.
Start with the workflows that create the most drag today. American manufacturers should not have to settle for software that was not built for the complexity of their work.