SR&ED for medical devices
Medical devices sit at a hard intersection: real engineering under real physical limits, wrapped in a lot of regulatory work that looks like R&D but usually isn't. Sorting the two is where most of the claim question lives.
The eligible work is the part where the outcome was technologically uncertain, not the paperwork that proves you got there.
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Where the eligible work usually is
- Solving a design problem — miniaturization, power, signal quality, biocompatibility — where the known approaches couldn't meet your requirement.
- Novel sensing, actuation or on-device algorithms whose behaviour genuinely couldn't be predicted in advance.
- Making a device work under a constraint — sterilization, implantability, a safety margin — with no established method.
- Systematic design iteration where each version tested a hypothesis against a real unknown.
What usually doesn't qualify
Designing to established methods, routine verification and validation that confirm a known specification, and the regulatory work itself — Health Canada or FDA submissions, standard 510(k) paperwork, quality-system documentation — generally aren't SR&ED. Combining existing components the expected way doesn't clear the bar either, however much testing it involves.
Evidence from design and test
Device programs run on records a claim can lean on: the design history file, verification and validation results, bench and biocompatibility data, firmware commit history, and the design iterations behind them. SREDlog connects GitHub for the firmware trail and organizes the uploaded design and test records against the project, keeping each claimed cost tied to its evidence.
Frequently asked questions
Usually not. Submissions, standard verification and quality-system work confirm and document a design; they don't resolve a technological uncertainty. The earlier experimental development that does can be eligible.
Only if integrating them required resolving a genuine technological unknown. Assembling proven parts the expected way is routine engineering, even when it's demanding.
The design history file, V&V data, bench results and firmware history are strong contemporaneous records. See evidence management.
Separate the R&D from the regulatory work
Start a free trial and let SREDlog surface the genuinely experimental design work from your own records.
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This guide is general information, not tax advice. SR&ED rules, rates and limits change, so confirm the current figures with the CRA or your advisor before you file.