iec-62304

---
name: iec-62304
description: "IEC 62304 medical device software lifecycle framework. Risk classification, software safety classification (A/B/C), design control, verification, validation, and regulatory documentation for FDA/EU MDR submissions."
tags: [iec-62304, medical-device, regulatory, compliance, fda, safety, zorai]
---
## Overview

IEC 62304 medical device software lifecycle framework. Software safety classification (Class A/B/C), design control, verification, validation, and regulatory documentation for FDA and EU MDR submissions.

## Software Safety Classification

- **Class A** -- No injury or damage to health (e.g., log viewer)
- **Class B** -- Non-serious injury (e.g., infusion pump alarm)
- **Class C** -- Death or serious injury (e.g., radiation therapy planning)

## Key Processes

- **Design Control** -- Requirements -> Design -> Implementation -> Verification -> Validation
- **Risk Management (ISO 14971)** -- Hazard identification, risk estimation, risk control
- **Software Change Management** -- Change classification (bug fix, enhancement, new feature)
- **Problem Resolution** -- CAPA for software defects
- **Cybersecurity** -- Threat modeling, vulnerability management

## Documentation Checklist

```
- Software Development Plan
- Software Requirements Specification
- Software Architecture Document
- Software Detailed Design
- Software Unit Verification
- Software Integration Testing
- Software System Testing
- Software Release Notes
- Software Maintenance Plan
- Software Risk Management File
```