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Medical Device Software Version Monitoring and Case Study

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Software is not a tangible product. We can ensure the software quality only through the status management. Because the software version can help us recognize the software status, it plays a very important role in the medical device quality monitoring. If there is no software version, it is not only hard to control the software modification but also the quality of the software control.

According to official statistics from December 2015 to the middle of April 2017, 43% medical devices recalled because of the software problems. The main reason was that the software safety performance was insufficient. And the software version was closely connected to the software quality control so we can see the importance of the medical device version update.


The necessity of medical device software version monitoring:

China monitoring regulation requires the overseas medical devices that already access their local market can do the accessing market application in China, but China still do not work on oversea medical device manufacturing enterprises’ quality system evaluation and have not checked the software version. If there is no requirement for the software version during the accessing market audit, audit will have omission.

For example: One oversea software 1.0 already sold in the local market. But after the major change, the 2.0 version product still keep the same name and not sell in the local market. Thus this company does not do the application for accessing market which means the new software version 2.0 do not have the selling permission in their original country. And if this company cannot provide the official certificate that the updated software version get the selling permission in the original manufacturing country, at the same time, the software version 2.0 send the application and get the permission to access Chinese market. Based on this situation, this company violate Chinese audit regulation.

In the same way, the medical device software version will also have this problem. Therefore, China medical device software audit must match up with software version checking. Audit department should keep eye on quality management system examination, before accessing market permission and after accessing market audit, etc.

On the other hand, the naming principles for the medical device software and software engineering are not exactly the same. The software version naming should be based on the audit requirement, especially for the software alternation audit requirement. However, the audit department requires medical device send the new accessing market application whenever the medical device updated. And for the correction change and inner structure are controlled by the quality management system.

Case Study:

In October 2011, one FDA law-enforcement officer checked the radiology department in a medical institution. He found that the imported CT machine’s three dimension vision screen showed the software version was A4.1. But on the certification provided by this medical institution, the registered software version was A3.9. And these two version were exactly different. This medical institution explained that their medical device supplier updated their medical device during the contract period, but the supplier identified this update without any essential differences. However, from the FDA’s point of view, the new version software A4.1 is not the registered product A3.9. And later this medical institution provided the new registration certification. The register date was March 31th 2012. Finally FDA decided this medical institution still violate the regulation ‘Medical Device Audit Management regulation’. Whereas, this medical institution positively cooperate with the inspection and get the accessing market certification during the inspection. FDA reduces the punishment for this medical institution.

  

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