Hi friends!!!

In our previous blogs, we have discussed about the following topics.

In today’s blog, we are going to discuss about IEC 62304.

IEC 62304 states the requirements for Medical Device Software. Satisfying the requirements of IEC 62304 is an important task in order to ensure the safety of patients and efficacy of software used in treating the patients.

Therefore, it is important for Medical Device QA/RA Professionals to understand about Software Development Planning requirements as per Clause 5.1 of IEC 62304.

Let’s get into the topic.

Software Development Planning

The Software Development Planning is an
important part of Software Development Process. The Software Development
Planning shall consider the following details as per IEC 62304.

Software Development Plan:

The Software Development Plan shall address the
following:

The information about the process used in the
development of Software System shall be provided.

The Information about the deliverables or
documentation for each activity and tasks in Software Development Process shall
be provided.

The information about the Traceability between
System requirements, Software Requirements, Software System Testing and Risk
Control Measures implemented shall be provided.

The information about the Configuration of the
Software & Change Management shall be provided. It shall also include
information about SOUP Configuration Items and other Software’s used to support
the Software development process.

The information about the Problem Resolution
process of software shall be provided for handling problems in the Software
products, deliverables and activities during each stage of Software Life Cycle.

Update to Software Development Plan:

The Software Development Plan shall be updated
as necessarily during the Software Development Life Cycle process with
appropriate version controls.

Reference to System Design and Development:

System Requirements Document, other procedures
for coordinating the Software Development activity and Design & Development
validation activity shall be referenced in the Software Development Plan.

Standards, Methods and Tools:

The Standards, Methods & Tools used in the
Software Development Process shall be referenced in the Software Development
Plan.

Software Integration and Integration Testing
planning:

A plan to integrate multiple software items and
testing that needs to be performed during the integration shall be referenced
in the Software Development Plan.

Software Verification planning:

There shall be information about the
deliverables requiring verification and acceptance criteria for the
verification of deliverables in the Software Development Plan.

Software Risk Management planning:

The Plans related to tasks and activities of
Software Risk Management Process shall be addressed in Software Development
Plan. The information related to managing the risks of SOUP shall also be
addressed in Software Development Plan.

Documentation planning:

The information about the documents that needs
to be produced during the Software Development Life Cycle shall be referenced
in Software Development Plan.

The Documents shall have an appropriate Title,
Name, Purpose, information about the Intended Audience of the document,
Procedures and Responsibilities for development, review, approval and
modifications of the document.

Software Configuration management planning:

The information about the Software
Configuration Management shall be referenced in Software Development Plan. The
information shall have details about, but not limited to the following:

The Activities and Tasks in Software
Configuration Management.

The Class, type, category or list of items that
needs to be controlled.

The Responsible Persons and Designations for
performing Software Configuration management activities.

Impact or relationship of the configuration
with the other functions of the organisations such as development and
maintenance.

Details about when the item needs to be placed
under configuration management and when the problem resolution process shall be
used.

Control of Configuration items before
verification:

There shall be a plan specified by the
manufacturer of Software to place the configuration items under documented
configuration management control before they are verified.

Now I hope you have acquired some basic knowledge about Software Development Planning requirements as per Clause 5.1 of IEC 62304. We will meet again with another valuable topic related to Biomedical Engineering, Medical Device, Healthcare.

NOTE: Dear friends!!!… Please do comment a topic related to Biomedical, so that we can discuss it in future blogs.

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