Formal System Testing for Medical Devices – Part 1

A health care researcher working in a laboratory

The medical device development process relies on ‘requirements.’ Every device relies on requirements to dictate its function, but in a partnership between designers and medical device developers, both parties must agree on your device’s prerequisites. This agreement is critical because requirements can drastically impact your product’s schedule, budget, and quality output. After deciding upon the requirements for a medical device, the rest of the development process can begin.  

The Need for Medical Device Testing

Medical device testing is crucial at the end of a project to ensure your device meets each requirement adequately. But how do medical device development companies test these requirements at the end of the line? A medical device development company will rely on formal system testing to accomplish this task.

There are two aspects of medical device testing: verification and validation. Minnetronix focuses on verification—often deferring validation to their customers because they have easier access to system users. In this two-part blog, we’ll cover every aspect of device verification, so you can know how development companies will verify your invention at the end of production.

What is Device Verification?

Verification is the process of guaranteeing the design was implemented correctly. This process ensures that the system and subsystem requirements have been met in the design. Verification simply asks the question, “Was the product developed correctly?”

Properly executed verification can positively impact the project outcome and provide necessary information for regulatory submissions. Before this aspect of the medical device testing process can begin, preparation must occur.

Preparation for Verification

Verification test preparation should begin early in the development process, with test engineers at the table throughout the development process. Ensuring the project is testable, verifiable, and that the protocol is appropriately designed is vital. There are a plethora of reasons for each of those characteristics.

  • TestabilityAs requirements are documented, a quick check for testability involves asking, ‘How will this requirement be tested?’ This check helps to refine the criteria and makes them easier to understand. 
  • Verifiable – One characteristic of adequate requirements is that they are verifiable. This term means requirements can be quantitatively evaluated for implementation. The test protocols provide the step-by-step instructions to complete this quantitative evaluation and the acceptance criteria, which show if the requirement is met.
  • Protocol Design – Each protocol may verify more than one requirement. It generally makes sense to group related requirements in the same protocol. Effective protocol design also relies on traceability. Test protocols should be traced from the requirements which they verify. Setting up traceability early can track the impact of requirements changes.

Minnetronix creates the design and test protocols in a highly collaborative environment. The Minnetronix verification team is involved in requirements reviews to ensure they are testable and verifiable from the beginning. The group begins to write test protocols once appropriate stakeholders have agreed to the requirements and an initial architecture has been defined.

The design team and the quality engineers work closely during the development effort to ensure appropriate testability. By starting work on the protocols as soon as possible, issues such as holes, conflicts, and redundancies of requirements can be easily identified and addressed early. Correcting problems as early as possible lessens the impact of project costs and timelines.

Minnetronix works with you to set requirements and facilitate the device verification process. In part two, we’ll cover the initial dry run and the formal verification process of your medical device. Find out how we accelerate breakthroughs by visiting our page. Contact us to bring your product to fruition and help clinicians and their patients. 

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