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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