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 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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