It is a fact that no medical device provider would want to market a product filled with bugs and errors. A device with faulty software will not even get approved by the authorities, which would cause the manufacturer to suffer huge financial losses. There are also chances of issues arising after a release, which mainly occurs because of incorrect software updates or extensive use of the device.
Launching low-quality software will also affect the users' well-being. For example, using low-quality software in medical diagnostic devices that gives incorrect data to make a therapeutic decision can be extremely harmful for the patient. Moreover, in cases of insufficient software security, the health information of patients will be at risk, which is against HIPAA regulations. That’s why it is necessary to conduct medical device software testing before product launch.
Best Practices To Follow
To launch a good quality medical device and make sure it passes FDA review, a medical device software provider needs to ensure their QA process consists of the following practices:
Proper Test Documentation
There should be thorough and complete test documentation of the verification and validation activities that have been performed on the medical device. Based on the software’s concern level, the list would include the following documents:
- Minor Level: A test result report with identified pass/fail criteria. It should provide details regarding the test cases software passed and failed.
- Moderate Level: Detailed description of validation and verification activities performed at system, unit, and API levels with a complete test results report.
- Major Level: Unit, system, and API level test protocols with pass/fail criteria, along with a description of validation and verification activities with a complete test results report.
End-to-End Requirement Traceability
The first step is to specify the risk treatment, compliance, and business requirements with test design documents and technical requirements. Following this, reflect the mapping in the requirements traceability matrix. It will make sure that all the technical requirements get covered with test cases, hence speeding up the testing process, and facilitating debugging.
Prioritizing Testing Activities
For testing a medical device software, you have to run a series of different QA tests. The first step is to make a list of prioritized test activities based on the software components risk level. Following this, validate the components with the higher risk value first in the software delivery life cycle.
As medical device software needs to be of high quality and should comply with dozens of regulations, the quality assurance and testing process need to be planned and executed carefully. The best way is to outsource medical device software testing to a trusted organization, such as QASource. If you want assistance in handling QA and testing-related tasks, contact QASource now.