Formal System Testing for Medical Devices – Part 2

Health care researchers working in medical science technology research in a laboratory

Verification is critical for medical device testing, which is why we recommend reading part one if you haven’t already. In part one of this series, we examined the need for medical testing and briefly covered the first few aspects of device verification. In this article, we’ll cover the verification dry run and the formal verification process that makes new medical products a reality. 

The Verification Dry Run 

Once initial prototypes are available, the protocols for medical devices may be run. This dry run is a rehearsal of the verification testing, which evaluates how well the test protocol performs. Dry run testing can also make an initial evaluation of whether medical device requirements have been implemented correctly.

Dry runs identify issues with the test protocol (i.e., steps that cannot be completed as described) or problems with the design (i.e., features which have not been implemented as described). Identifying and addressing these issues before a formal verification is crucial because correcting them later in the project is more challenging and expensive.

After completing dry run testing, the protocols are updated with the new findings in mind. The updated verification protocols are reviewed with the appropriate stakeholders before beginning formal verification.

Minnetronix strongly advocates for dry run testing within a project’s schedule. The additional investment is well worth it because dry runs identify issues before design completion.

Executing Formal Verification

Formal verification testing can begin once the verification protocols are written, reviewed, released—and a final prototype is available. If the test protocols were comprehensively dry run before formal testing, little new information should surface. However, it is always possible that further issues may arise. These issues can be addressed in various ways, utilizing your team’s expertise.

Any design changes that occur after formal verification (including changes made to address test failures) may require regression testing. Regression tests evaluate design changes and assess their impact throughout the requirements, design, and verification stages. These design changes may be limited in scope—requiring only a handful of tests to be redone. As an alternative, they may impact enough of the design that it is necessary to re-execute the entire suite of tests.

The outcome of the verification phase is a set of documents outlining the final version of the requirements, along with reports showing that either the requirements were met or not met. If some requirements are not met, the documents will include rationales. These rationales explain why some conditions weren’t met and why the failure to meet those conditions is acceptable. 

The Medical Device Development Process

Verification is an essential phase in the medical device development process because it can positively impact the project and provide necessary information for regulatory submission.

Minnetronix seamlessly integrates quality assurance into the medical device development process. Although this can increase the upfront investment, the overall project cost decreases. Factoring in each stage of the process from the beginning helps ensure issues are identified and addressed early rather than at the last minute. This careful practice ultimately saves the customer time and money.

Our experience in managing formal verification efforts can help ensure a smooth testing effort, resulting in more predictable project costs and timelines. When you need help accelerating your next breakthrough, contact the team at Minnetronix.

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