Implementing COTS Antivirus Solution for Medical Device Manufacturing Plants

Ensuring Interoperability: Testing Software and Instruments

Question

A medical device company is implementing a new COTS antivirus solution in its manufacturing plant.

All validated machines and instruments must be retested for interoperability with the new software.

Which of the following would BEST ensure the software and instruments are working as designed?

Answers

Explanations

Click on the arrows to vote for the correct answer

A. B. C. D. E.

B.

The BEST option to ensure that the new antivirus software and medical instruments are working together as expected is User acceptance testing (UAT), which involves testing the system from a user's perspective to ensure that it meets the requirements and functions as intended.

Option A, system design documentation, is important for understanding the design and architecture of the system, but it does not guarantee that the antivirus solution will work with the medical instruments.

Option C, peer review, is a valuable method of ensuring the quality of the system, but it is not specific to testing the interoperability between the antivirus software and medical instruments.

Option D, static code analysis testing, is used to identify potential vulnerabilities and errors in the code, but it is not specific to testing the interoperability of the antivirus software and medical instruments.

Option E, change control documentation, is important for managing changes to the system, but it does not guarantee that the antivirus software will work with the medical instruments.

Therefore, User acceptance testing (UAT) is the best option to ensure that the new antivirus software and medical instruments are working together as expected. UAT helps to identify any issues or bugs that may have been missed during the development and testing phase, allowing for any necessary changes to be made before the system is fully implemented.