GSPR Compliance
Available Plans
Pro / Max / CRO
Overview
The GSPR (General Safety and Performance Requirements) workflow systematically evaluates device compliance against EU MDR Annex I requirements, generating a complete GSPR compliance checklist.
Annex I Structure
| Chapter | Requirements | Content |
|---|---|---|
| Chapter I | GSPR 1-9 | General requirements |
| Chapter II Part A | GSPR 10-16 | Chemical/physical/biological |
| Chapter II Part B | GSPR 17-22 | Software/cybersecurity/radiation |
| Chapter III | GSPR 23 | Labeling and instructions |
Workflow Steps
- Step 1: Chapter I (GSPR 1-9) -- General safety requirements
- Step 2: Chapter II Part A (GSPR 10-16) -- Material and biological requirements
- Step 3: Chapter II Part B (GSPR 17-22) -- Software and cybersecurity
- Step 4: Chapter III (GSPR 23) -- Labeling requirements
- Step 5: Final document assembly
Intelligent Features
Device Type Applicability
AI identifies the device archetype (SaMD / hardware-software / physical) and automatically determines clause applicability:
- Pure software: material/biological clauses marked N/A
- Physical devices: software/cybersecurity clauses marked N/A
Cross-References
Automatically references data from CE and Risk Management tasks in the same project.
Output
Landscape-format multi-column table with: GSPR No., General Requirement (full Annex I text), Comply (Y/NA), Method of Demonstration, Document Reference.