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 Requirements Analysis as per Clause 5.2 of IEC 62304.

Let's get into the topic.

Software Requirements Analysis

Software Requirement Analysis is a means of defining and documenting the needs and expectations from end users and stakeholders about the software products that are important and needed to be fulfilled by the Software.

The following are the overview of key steps in performing Software Requirement Analysis:

Identify the right stakeholders and end users of the software product.

Capture requirements from the stakeholders and end users by establishing suitable means of communication.

Categorize the requirements. For e.g., as Performance Requirements, Technical Requirements etc.

Document the requirements and get alignment from the stakeholders and end users to proceed with the implementation phase.

For each Software System of the Medical Device, the Software System requirements derived from the System level requirements shall be defined and documented by the manufacturer of the Medical Device Software. If the Software System is a stand-alone Software only device, there may not be any difference between the Software System Requirements and System level requirements.

Software Requirements Content:

As appropriate, the Software requirements of the Medical Device Software shall include the following information, but are not limited to:

The Functional and Capability requirements. For e.g., Information about Performance requirements, Physical Characteristics, Computing Environment and Compatibility of the Medical Device Software.

Information about the alarms, warnings, and operator messages which are software driven.

Security requirements of the Medical Device Software.

User interface requirements implemented by the Medical Device Software. For e.g., information about human-equipment interactions etc.

Information about the Inputs and Outputs of the Software System, Interfaces between Software Systems and other Systems.

Installation and acceptance requirements of the Medical Device Software delivered at the site of operation and maintenance.

Information about the Regulatory requirements of the Medical Device Software.

Security requirements of the Medical Device Software.

Requirements related to IT-network aspects of the Medical Device Software. For e.g., Information about Network protocols, Information about handling of unavailability of network services.

Information related to methods of operation and maintenance of Medical Device Software.

Data definition and Database requirements.

Risk Control Measures in Software Requirement:

The Risk Control measures implemented in the Medical Device Software shall be included in the Software System requirements by the manufacturer. These requirements may not be available at the initial stages of the software development. These requirements might change when the software is designed and when risk control measures are further defined.

Re-evaluate Medical Device Risk Analysis:

The Medical Device’s risk analysis shall be re-evaluated by the manufacturer when the software requirements is established and updated as appropriate.

Update requirements:

All other existing requirements, along with System level requirements shall be re-evaluated and updated as appropriate by the manufacturer, whenever there is any change to the Software system requirements.

Verification of Software Requirements:

The following aspects of the Software requirements shall be verified and documented by the manufacturer:

Software requirements shall be suitable for establishment of test criteria and performance of the tests.

Software requirements shall be uniquely identified.

Software requirements shall not contradict with one another.

Each Software requirement shall be traceable to System requirements and other sources.

Now I hope you have acquired some basic knowledge about Software Requirement Analysis as per Clause 5.2 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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