Hi friends!!!
In our previous blogs, we have discussed about the following topics.
IEC 62304 Software Maintenance Process
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 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.
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