Hi friends!!!
In our previous blogs, we have discussed about the following topics.
IEC 62304 Overview & Definitions
IEC 60601-1 Classification of Medical Electrical Equipment
IEC 60601-1 General Requirements for Testing Medical Electrical Equipment
IEC 60601-1 Medical Electrical Systems
IEC 60601-1 Protection against unwanted and excessive radiation hazards
IEC 60601-1 General Requirements
IEC 60601-1 Programmable Electrical Medical Systems
IEC 60601-1 Hazardous situations and fault condition
IEC 60601-1 Construction of Medical Electrical Equipment
IEC 60601-1 Leakage Currents and Patient Auxiliary Currents
IEC 60601-1 Creepage Distance and Air Clearance
IEC 60601-1 Components and Wiring
IEC 60601-1 Mechanical Hazards Moving Parts
IEC 60601-1 Excessive Temperatures
IEC 60601-1 Markings on the Outside of Medical Electrical Equipment
IEC 60601-1 Markings on the Inside of Medical Electrical Equipment
IEC 60601-1 Instability Hazards
IEC 60601-1 Separation of Parts
EU MDR Timeline, Annex, Chapter
EU MDR Post Market Surveillance
EU MDR Technical Documentation – Part 1
EU MDR Technical Documentation – Part 2
EU MDR General Safety and Performance Requirement
EU MDR Information on the Label
EU MDR Post Market Clinical Follow Up
EU MDR Unique Device Identification – Part 1
EU MDR Unique Device Identification – Part 2
EU MDR Chapter & Articles – Part 1
EU MDR Chapter & Articles – Part 2
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.
Check out for this blog about Computed Tomography, X ray, MRI scan, ECG.
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