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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