Medical device teams spend months planning verification and validation. Test protocols are approved, samples are prepared, failures are investigated, and the design history file grows. When SR&ED enters the discussion, the tempting shortcut is to treat all of that testing as research.
The labels on the protocol do not settle the question. The reason for the test, the knowledge available when it began, and what the team did with an unexpected result matter more.
Start with the question behind the test
Consider a catheter made with a known material, geometry, and manufacturing process. The team runs a prescribed test to confirm that the finished device meets an established specification. That work may be essential for design controls and regulatory evidence. It can still be routine testing for SR&ED purposes because the expected result and the method for assessing it are already understood.
Now change the facts. The material behaves unpredictably after sterilization. Available literature, supplier data, and standard engineering practice do not explain how to maintain flexibility without losing strength. The team develops possible explanations, changes the material or process, and tests each version to learn which relationships hold.
The second situation may contain SR&ED because the experiments are directed at a technological uncertainty. The team's objective is to gain knowledge needed to develop or improve the device, not simply to confirm compliance with a known requirement.
One development program can contain both kinds of work
Medical device development rarely divides into neat tax categories. A single prototype may be used for experimental testing, usability work, regulatory verification, and a commercial demonstration.
The claim needs to identify the investigation that pursued scientific or technological advancement. Under the CRA's current eligibility guidance, engineering, design, data collection, computer programming, and testing can support eligible work when they are commensurate with its needs and directly support it.
Quality control, routine testing, market research, commercial production, and routine data collection are excluded. A required activity does not become eligible because it appears in the same project plan as experimental work. The file should show where the investigation began, what the team was trying to learn, and when the work returned to a known verification path.
Regulatory evidence answers a different question
Health Canada's medical device framework addresses safety, effectiveness, quality, licensing, and post-market responsibilities. Its guidance includes clinical evidence requirements and quality-system expectations, including ISO 13485 requirements for relevant device classes.
Those processes can produce useful contemporaneous records, but they do not determine SR&ED eligibility. A successful regulatory test may follow a standard method and produce the expected result. A failed prototype may still contribute to SR&ED if it was part of a systematic investigation and helped the team understand why a material, component, algorithm, or process behaved as it did.
The distinction also runs the other way. Repeating a failed test without a reasoned hypothesis, changing several variables without a plan, or collecting results without drawing conclusions may not demonstrate the systematic investigation the CRA describes.
Use the design history to reconstruct the investigation
Design inputs, risk files, test plans, non-conformance reports, prototype records, software versions, and change histories often contain the raw material for an SR&ED record. The useful account is usually spread across several documents.
A test report may describe an unexpected failure. A design review records the proposed explanation. A later prototype isolates one variable. The analysis explains what the result changed in the team's understanding, including what remained unresolved.
Bring those records into one chronology. For each experimental step, record:
- the limitation in available scientific or technological knowledge;
- the idea or hypothesis being tested;
- the prototype, method, or variable that changed;
- the observation and the conclusion drawn from it;
- the people, time, and costs tied to that work.
This chronology also makes exclusions easier to defend. Routine release testing, certification work, production support, and commercial demonstrations can be separated from experiments that directly addressed the uncertainty.
Review the boundary while the records are available
Waiting until claim preparation often leaves the technical team reconstructing why a test was run months earlier. A short review after a failed test or design change can preserve the decision that the formal protocol does not capture.
Our overview of SR&ED for medtech companies explains how the program fits into a broader development and funding plan. The SR&ED calculator can help frame a preliminary funding discussion, but eligibility still depends on the work and the evidence behind it.
If your verification plan contains both routine confirmation and unresolved technical questions, contact MITRAS to review the boundary before the development record goes cold.
Sources reviewed September 21, 2026.