Thursday, November 30, 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 Configuration Management & Problem Resolution Process requirements as per Clause 8 & 9 of IEC 62304.

Software Configuration Management Process

Configuration Identification

A scheme for unique identification of configuration item and its version to be controlled shall be established by the manufacturer of the medical device software according to the development and configuration planning.

The configuration items and its versions comprising the software system configuration shall be documented by the manufacturer of medical device software.

The details of the SOUP Configuration items for example title, manufacturer details & unique SOUP designator shall be documented by the manufacturer of the medical device software. The unique SOUP designator can be a version, release date, patch number or an upgrade designation.

These requirements are applicable for Class A, B & C, medical device software.

Change Control

A configuration items shall be changed by the manufacturer of the medical device software only after the approval of change requests. The Change control process should be followed for making decisions regarding the approval of change requests.

The change shall be implemented as specified in the change requests. Activities that need to be repeated because of change implementation shall be identified and performed by the manufacturer of the medical device software. The implemented change shall be verified by the manufacturer.

The details regarding the dependencies & relationships between change requests, approval of change requests, related problems reports shall be maintained by the manufacturer of the medical device software.

The details regarding the history of controlled configuration items including the system configuration shall also be maintained by the manufacturer of the medical device software.

These requirements are applicable for Class A, B & C, medical device software.

Software Problem Resolution Process

Each problem detected in the medical device software shall be recorded in the problem report by the manufacturer of medical device software. The problem reports shall include information about the criticality of the problem detected in the medical device software & any other information that can help in the problem resolution.

Problems can be discovered before or after the release of medical device software into market. Problems can also be discovered inside or outside of the manufacturer’s organization.

Each problem shall be investigated to identify the root cause & outcome of the investigation shall be documented by the manufacturer of the medical device software. Any actions needed for the resolution of problem can be proceeded via creation of change requests. If there are no actions required, a rationale can be provided.

The above change control steps shall be followed for the approval & implementation of change requests.

All the relevant parties depending upon the situation shall be advised about the existence of the problem by the manufacturer of the medical device software.

Appropriate records for problem reports, their resolution & verification shall be maintained by the manufacturer of the medical device software.

The problem reports shall be analyzed for any trends. The resolution shall be verified by the manufacturer of medical device software with respect to adverse trends, complete implementation of change requests and closure of problem reports.

The relevant test documentation with appropriate details shall be maintained by the manufacturer of medical device software.

These requirements are applicable for Class A, B & C, medical device software.

Now I hope you have acquired some basic knowledge about Software Configuration Management & Problem Resolution Process as per Clause 8 & 9 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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Sunday, October 29, 2023

IEC 62304 Software Maintenance Process

Hi friends!!!

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

IEC 62304 Software System Testing

IEC 62304 Software Unit Implementation & Integration

IEC 62304 Software Architectural & Detailed Design

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 Maintenance Process requirements as per Clause 6 of IEC 62304.

Software Maintenance Process

The Software Maintenance is performed once the medical device software is released in the market. There are multiple reasons for performing maintenance activities which includes correcting issues & bugs and to keep up with the customer needs etc. IEC 62304 states the requirements for Medical Device Software Maintenance Process.

Software Maintenance Plan

The Software Maintenance Plan shall be established by the manufacturer of the medical device software. The Software Maintenance Plan shall address the following:

The Procedures for addressing the feedbacks once the medical device software is released into the market.

The Criteria for determining whether the feedback can be considered as a problem.

The Problem resolution process & Configuration Management Process.

The Procedures for evaluating and implementing the upgrades, bug fixes, patches, obsolescence of SOUP.

These requirements are applicable for Class A, B & C, medical device software.

Problem and Modification Analysis

Document and Evaluate Feedback:

The feedbacks of the market released medical device software shall be monitored, documented and evaluated by the manufacturer of the medical device software to determine the existence of problems in the released medical device software.

The Problems identified shall be recorded in Problem Report as per Problem Resolution Process specified in IEC 62304.

The Problem Report shall include deviations from specification and actual or potential adverse events.

The effects of the problem on the safety of the medical device software released into the market shall be evaluated in the Problem Report. The changes needed in the medical device software for addressing the problem shall also be evaluated in the problem report.

The requirement is applicable for Class A, B & C, medical device software.

Software Problem Resolution Process & Change Requests:

The Problem Resolution Process as per IEC 62304 shall be used by the manufacturer of the medical device software to address problem reports.

In addition to the Problem Resolution Process, each change requests raised to address the problem shall be analyzed by the manufacturer with respect to its effect on released medical device software and the systems with which it interfaces, and the organization.

Each change requests which modify the released medical device software shall be evaluated and approved by the manufacturer. The Change request means a documented specification about the change.

The Users and Regulators shall be communicated by the manufacturer about any problems in the released medical device software. The Users and Regulators shall also be communicated about the consequences of continued unchanged use of the software.

The requirement is applicable for Class A, B & C, medical device software.

Implementation of Modification

Software Development Process as per IEC 62304 need to be identified and repeated by the manufacturer of medical device software for implementing the required software modification.

Modifications made to the software shall be released by the manufacturer of medical device software. The release can be a full re-release of software system or only as a software item comprising of changes and tools to install the changes to an existing system.

The requirement is applicable for Class A, B & C, medical device software.

Now I hope you have acquired some basic knowledge about Software System Maintenance Process as per Clause 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

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!

Saturday, September 23, 2023

IEC 62304 Software System Testing

Hi friends!!!

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

IEC 62304 Software Unit Implementation & Integration

IEC 62304 Software Architectural & Detailed Design

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 System Testing & Software Release requirements as per Clause 5.7 & 5.8 of IEC 62304.

Software System Testing:

The software system testing is the process of validating the fully integrated and complete software including the external peripherals to check the interaction of software components with one another and with the entire software system.

The following are the requirements of software system testing as per IEC 62304:

The set of tests, its expected outcomes, acceptance criteria & procedures for conducting software system testing shall be established by the manufacturer of medical device software, to cover all the software requirements. This requirement is applicable for Class A, B & C, medical device software.

The adequacy of the strategy used for verification and test procedures shall be evaluated by the manufacturer of medical device software.

Single test procedure can be used to verify a combination of software requirements, if there is a dependency between requirements.

If required, both software system testing and software integration testing can be combined in a single plan with a single set of activities.

Addressing Anomalies:

The anomalies found during the software system testing can be entered and addressed by the manufacturer of medical device software via software problem resolution process. This requirement is applicable for Class A, B & C, medical device software.

Retesting:

If changes are made to correct the problems during software system testing, appropriate additional testing activities need to be performed to ensure the effectiveness of the change. The testing’s performed after the change shall ensure that no new unintended side effects have been introduced. This requirement is applicable for Class A, B & C, medical device software.

The manufacturer of the medical device software shall ensure that all software requirements are verified & tested. The test results shall meet the acceptance criteria. Traceability shall be established between software requirements & verification activities. This requirement is applicable for Class A, B & C, medical device software.

Software Release:

The manufacturer of medical device software shall ensure the following points before the release of medical device software for utilization at a system level:

All verification activities of the medical device software shall be completed and results shall be evaluated by the manufacturer.

All residual risks identified shall be documented and evaluated by the manufacturer to ensure that the residual risks do not contribute to any unacceptable risks.

The environment and procedures used to develop the medical device software shall be documented by the manufacturer.

Appropriate completion of all the activities and associated documentation mentioned in software development plan shall be ensured by the manufacturer.

Appropriate version of medical device software to be released shall be documented by the manufacturer.

The procedures shall be established by the manufacturer of the medical device software to ensure that the released medical device software can be delivered to the appropriate point of use in a reliable manner without any unauthorized changes and corruption to the software.

All software related configuration items & documents shall be archived by the manufacturer till the life time of the medical device software or as specified by the appropriate regulatory requirements.

Now I hope you have acquired some basic knowledge about Software System Testing & Software Release as per Clause 5.7 & 5.8 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