ISO 62304

Medical Device Software Lifecycle Processes for HealthTalk.

Overview

IEC 62304:2006+AMD1:2015 defines the life cycle requirements for the development of medical device software and software within medical devices. It applies to the design and development of HealthTalk.

Software Safety Classification

HealthTalk is classified as Class B software:

Software system could contribute to a hazardous situation
Injury would not be life-threatening

Software Development Process

5.1 Software Development Planning

Software development plan documented
Development standards defined
Tools and methods specified
Verification activities planned

5.2 Software Requirements Analysis

System requirements captured
Software requirements derived
Traceability maintained
Risk analysis inputs incorporated

5.3 Software Architectural Design

Architecture documented
Interface specifications defined
Component breakdown established
Design patterns applied

5.4 Software Detailed Design

Module specifications
Algorithm definitions
Data structure designs
Error handling approaches

5.5 Software Unit Implementation

Coding standards applied
Unit testing performed
Code review conducted
Static analysis tools used

5.6 Software Integration and Testing

Integration plan executed
System testing performed
Regression testing automated
Test evidence documented

5.7 Software System Testing

Validation testing completed
User acceptance testing
Performance testing
Security testing

Maintenance Process

Problem and modification analysis
Change impact assessment
Configuration management
Release management

Documentation

All software lifecycle documentation is maintained in the Design History File (DHF).