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 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.

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