SR&ED for medical devices
The same design history file can contain experimental engineering, routine verification and regulatory evidence.
Those records serve different purposes, even when they describe the same device.
An SR&ED review needs to isolate the technological question and the experiments used to pursue it. Compliance paperwork does not establish that investigation.
Find the engineering question inside the device program
- Miniaturization, power, signal-quality or biocompatibility work where known approaches could not meet the combined requirements.
- Sensing, actuation or on-device algorithm experiments whose behaviour could not be predicted from available knowledge.
- Design work under sterilization, implantability or safety constraints for which no established method resolved the problem.
- Material design iterations that tested a stated hypothesis and produced a technical conclusion.
Compliance has a different purpose
Designing by established methods and verifying a known specification generally fall outside SR&ED. Regulatory submissions and quality-system administration do not qualify on that basis alone. Testing or engineering may be support work only when it directly supports and is commensurate with eligible experimental work, so the purpose and allocation require review.
Use the design history as a chronology, not a conclusion
The design history file, bench and biocompatibility results, verification records, firmware history and design changes can show how the work progressed. They still need context: which record belongs to the investigation, which confirms a requirement, and what conclusion followed.
SREDlog can bring approved GitHub activity into the project and organize uploaded design and test records beside reviewed costs.
Frequently asked questions
Not on that basis alone. Testing may be eligible support work only when it directly supports and is commensurate with eligible experimental work. Review its purpose and allocation separately from submission and administration activity.
No. Assembly by known methods is routine engineering. Review any separate integration investigation against the CRA's advancement and systematic-investigation requirements.
Connect design versions, firmware, test setups and results on the same timeline. Mark whether each test explored an unknown or confirmed a known requirement. See evidence management.
Separate the investigation from the submission record
Start a free trial and organize one project's design history, test results and firmware records.
7-day free trial · No credit card required
These industry examples are prompts for a fact-specific review, not categories guaranteed to qualify. Work must be conducted in Canada and meet both current CRA requirements; support work must directly support and be commensurate with eligible work. This is general information, not tax advice, and has not been reviewed by an independent qualified tax professional. See our editorial policy.