Saturday, August 5, 2023

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 Unit Implementation, Integration & Integration Testing requirements as per Clause 5.5 & 5.6 of IEC 62304.

Software Unit

As per IEC 62304, the Software Items which cannot be further decomposed are called as Software Units.

Software Unit Implementation:

The Manufacturer of the medical device software shall implement each software units. This requirement is applicable for Class A, B, C, medical device software.

The procedures, strategies and methods shall be established by the manufacturer of medical device software for verifying the software units. If the verification of software unit is done by testing, the adequacy of the test method shall be evaluated by the manufacturer. This requirement is applicable for Class B & C, medical device software.

Prior to integrating the software units with larger software items, the manufacturer of the medical device software shall establish the acceptance criteria for each software units and shall ensure that the software unit meets the acceptance criteria. This requirement is applicable for Class B & C medical device software.

The following factors can be considered for acceptance criteria:

The software code implements adequate risk control measures, free from contraindications with respect to the interface design, comply to applicable programming or coding standards.

The software unit verification shall be performed by the manufacturer of medical device software and results shall be documented. The software unit verification means verifying the software unit implementation against the software unit design. This requirement is applicable for Class B & C medical device software.

Software Unit Integration and Integration

Testing:

The manufacturer of medical device software shall integrate each software units. The integration of software units with software items and/or software system shall be verified by the manufacturer according to the software integration plan and evidence of such verification shall be retained. This requirement is applicable for Class B & C, medical device software.

The integrated software items shall be tested by the manufacturer of medical device software according to the software integration plan and the results shall be documented. Such integration testing procedures shall be evaluated for adequacy. This requirement is applicable for Class B & C, medical device software.

The intended performance of the integrated software items shall be addressed by the manufacturer of medical device software during the software integration testing. This requirement is applicable for Class B & C, medical device software.

The following factors can be considered during software integration testing:

The functionality of the software.

Appropriate implementation of risk control measures.

Specified timing and other behaviour of the software.

Specified functioning of internal and external interfaces of the software.

The software can be tested under abnormal conditions including foreseeable misuse.

The manufacturer of medical device software shall conduct the regression testing when software items are integrated, to ensure that no defect have been introduced into previously integrated software. This requirement is applicable for Class B & C, medical device software.

The software problem resolution process shall be used by the manufacturer of medical device software to enter details about the anomalies found during integration and integration testing. This requirement is applicable for Class B & C, medical device software.

The integration test records shall document the test results, identify the tester, have adequate details like equipment’s used for testing, environmental conditions, test case specifications etc., to enable the test to be repeated.

Now I hope you have acquired some basic knowledge about Software Unit Implementation, Integration & Integration Testing as per Clause 5.5 & 5.6 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.

Generations of CT Scanners

COMPUTED TOMOGRAPHY|TECHNOLOGY|ARTIFACTS

x ray machine working principle

components of x ray tube

MRI scan

MRI With Contrast

Brain MRI

Types of MRI scanners

ELECTROCARDIOGRAM

12 Lead ECG Placement

HOW TO READ AN ECG

Holter Monitor

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Saturday, July 1, 2023

IEC 62304 Software Architectural & Detailed Design

Hi friends!!!

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

IEC 62304 Software Requirements Analysis

IEC 62304 Software Development Planning

IEC 62304 Overview & Definitions

IEC 60601-1 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 Assessment Routes

EU MDR Timeline, Annex, Chapter

EU MDR Post Market Surveillance

EU MDR Clinical Evaluation

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 Classification Rules

EU MDR EUDAMED

EU MDR Economic Operators

EU MDR Chapter & Articles - Part 1

EU MDR Chapter & Articles - Part 2

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

Therefore, it is important for Medical Device QA/RA Professionals to understand about Software Architectural & Detailed Design requirements as per Clause 5.3 & 5.4 of IEC 62304.

Let's get into the topic with an overview of few important definitions for better understanding of this blog.

A Software can be decomposed into three categories: Software System, Software Items, Software Units. The top level is Software system and the bottom level which cannot be further decomposed is called Software Units. A Software System can be composed of one or more Software Items, a Software Item can be composed of one or more Software Units or decomposable Software Items.

Software System:

Software System means an integrated collection of Software Items which are organized to accomplish a specific function or set of functions in a medical device software.

Software Item:

Software Item means an identifiable part of a computer program. E.g., Source code.

Software Unit:

Software Unit means a Software Item which cannot be subdivided into other Software Items.

ARCHITECTURE

The Architecture means an organizational structure of a system or component.

SOFTWARE ARCHITECTURAL DESIGN

Transform software requirements into an architecture:

The Manufacturer of Medical Device Software shall transform the requirements of the medical device software identified in the Software Requirement Analysis into a documented architecture. The architecture describes the medical device software’s structure and identifies the software items. This requirement is applicable for Class B & C, medical device software.

Architecture for the interfaces of software items:

The Architecture which provides details about the interfaces between multiple software items, as well as between the software items and the components external to the software items shall be developed and documented by the Manufacturer of Medical Device Software. This requirement is applicable for Class B & C, medical device software.

Functional & Performance requirements of SOUP Item:

The Functional & Performance requirements of Software of Unknown Provenance (SOUP) Items required for its intended use shall be specified by the Manufacturer of Medical Device Software, if a particular Software Item is identified as a SOUP. This requirement is applicable for Class B & C, medical device software.

System Hardware & Software required by the SOUP Item:

The System Hardware & Software required for proper functioning of the Software of Unknown Provenance (SOUP) Items shall be specified by the Manufacturer of Medical Device Software, if a particular Software Item is identified as a SOUP. This requirement is applicable for Class B & C, medical device software.

Segregation necessary for risk control:

Any segregation between the software items which are required for adequate risk control shall be identified by the Manufacturer of Medical Device Software. The Manufacturer shall also state the necessary steps to ensure the effectiveness of such segregation. This requirement is applicable for Class C, medical device software.

Verification of Software Architecture:

The Manufacturer of Medical Device Software shall verify and document the Software Architecture with respect to the above-mentioned requirements. This requirement is applicable for Class B & C, medical device software.

SOFTWARE DETAILED DESIGN

Subdivide Software into Software Units:

The Manufacturer of Medical Device Software shall subdivide the software until it is represented as Software Units which cannot be further subdivided into Software Items. This requirement is applicable for Class B & C, medical device software.

Detail Design of each Software Units:

The Detailed Design needed for the correct implementation of each Software Units shall be documented by the Manufacturer of the Medical Device Software. This requirement is applicable for Class C, medical device software.

Detail Design for Interfaces of Software Units:

The Detail Design for any interfaces between the Software Units and the external components, as well as between Software Units shall be documented by the Manufacturer of Medical Device Software. This requirement is applicable for Class C, medical device software.

Verification of Detailed Design:

The Manufacturer of Medical Device Software shall verify and document the Software Detailed Design with respect to the above-mentioned requirements. This requirement is applicable for Class C, medical device software.

Now I hope you have acquired some basic knowledge about Software Architectural & Detailed Design Requirements as per Clause 5.3 & 5.4 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.

Generations of CT Scanners

COMPUTED TOMOGRAPHY|TECHNOLOGY|ARTIFACTS

x ray machine working principle

components of x ray tube

MRI scan

MRI With Contrast

Brain MRI

Types of MRI scanners

ELECTROCARDIOGRAM

12 Lead ECG Placement

HOW TO READ AN ECG

Holter Monitor

DON’T FORGET TO FOLLOW THIS BLOG PAGE

DROP YOUR MAIL ID TO GET IMMEDIATE UPDATES

If you find this blog post knowledgeable,

comment & share it with a friend!

Sunday, June 18, 2023

IEC 62304 Software Requirements Analysis

Hi friends!!!

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

IEC 62304 Software Development Planning

IEC 62304 Overview & Definitions

IEC 60601-1 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 Assessment Routes

EU MDR Timeline, Annex, Chapter

EU MDR Post Market Surveillance

EU MDR Clinical Evaluation

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 Classification Rules

EU MDR EUDAMED

EU MDR Economic Operators

EU MDR Chapter & Articles - Part 1

EU MDR Chapter & Articles - Part 2

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

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.

Check out for this blog about Computed Tomography, X ray, MRI scan, ECG.

Generations of CT Scanners

COMPUTED TOMOGRAPHY|TECHNOLOGY|ARTIFACTS

x ray machine working principle

components of x ray tube

MRI scan

MRI With Contrast

Brain MRI

Types of MRI scanners

ELECTROCARDIOGRAM

12 Lead ECG Placement