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 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 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.
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