IEC 62304:2006+A1:2015 summary

IEC 62304:2006+A1:2015 is a standard that specifies life cycle requirements for the
development of medical software and software within medical devices. Here is a summary of
the main points in IEC 62304:2006+A1:2015:

Scope and Application:

The standard applies to the development and maintenance of medical device software.
It covers the entire software life cycle, including software development, maintenance, and
risk management processes.
Software Safety Classification:

Introduces a three-level classification (Class A, B, and C) based on the potential harm that the
software failure could cause to the patient or user.
Software Development Process:

Defines a software development process framework, which includes planning, requirements

specification, architecture design, detailed design, unit implementation and verification,
integration and integration testing, system testing, software release, and software
maintenance.
Software Maintenance Process:

Outlines requirements for software maintenance activities, ensuring that changes to the
software are properly managed and controlled.
Risk Management:

Emphasizes the importance of risk management throughout the software life cycle.
Requires identification and mitigation of software-related risks to an acceptable level.
Configuration Management:
Establishes requirements for configuration management to ensure control and traceability of
software and its associated documentation.
Documentation:

Specifies documentation requirements at each phase of the software life cycle, including
plans, specifications, and records.
Verification and Validation:

Outlines activities for verification (confirmation that the outputs meet the specified
requirements) and validation (confirmation that the software meets user needs and intended
use).
Release of the Software:

Describes the process for releasing software, ensuring that it meets the specified requirements
and has been adequately tested.
Problem Resolution:

Requires procedures for handling and resolving software-related issues, including tracking,
analysis, and corrective actions.
Software Maintenance:

Provides guidelines for maintaining software, including the handling of changes and updates.
Software Development File:

Requires the creation and maintenance of a Software Development File (SDF) that
documents compliance with the standard.
It's important to note that the "+A1:2015" refers to Amendment 1, which includes additional
requirements and clarifications to the original 2006 version of the standard.

What documents are required?

IEC 62304:2006+A1:2015 specifies various documents that are required throughout the
software life cycle. The specific documents may vary depending on the complexity of the
software and the risk associated with its use. Here are some of the key documents typically
required:

Software Development Plan (SDP):

Describes the approach, activities, and tasks to be undertaken during the software
development life cycle. It outlines the overall strategy for software development.
Software Requirements Specification (SRS):

Defines the functional and non-functional requirements for the software. It serves as the basis
for design and verification activities.
Software Architecture Specification (SAS):

Describes the software architecture, including the structure and organization of the software
components. It provides an overview of the system's design.
Software Detailed Design Specification (SDDS):

Provides detailed information on the design of individual software units or modules. It

includes data structures, algorithms, and interfaces.
Unit Test Specification (UTS):

Outlines the test cases and procedures to verify that each software unit or module functions as
intended.
Integration Test Specification (ITS):

Specifies the test cases and procedures to verify the correct interaction and integration of
software units or modules.
Software System Test Specification (SSTS):

Defines the test cases and procedures to validate the complete software system against its
requirements.
Software Release Note (SRN):
Documents information about the released software version, including changes made, known
issues, and any specific instructions for users.
Risk Management File (RMF):

Captures the results of the risk management process, including identification, assessment, and
mitigation of software-related risks.
Configuration Management Plan (CMP):

Describes the procedures and tools for configuration management, ensuring the control and
traceability of software and associated documentation.
Problem Resolution Report (PRR):

Records information about problems, defects, or issues identified during development or

post-release, along with their resolutions.
Software Maintenance Plan (SMP):

Outlines the procedures for maintaining and updating the software throughout its life cycle.
Software Development File (SDF):

Compiles all the relevant documentation and records to demonstrate compliance with the
standard.
These documents collectively form the Software Development File (SDF), which serves as
evidence of compliance with IEC 62304:2006+A1:2015. The specific content and details of
each document may vary based on the organization's processes and the nature of the medical
device software being developed.