QA & Design Control
We support medical device development by helping teams structure design controls, traceability, risk management, verification activities, and documentation around the real engineering work.
Our goal is to make development clearer, more defendible, and better aligned with the expectations that regulated products typically require.
What We Do
We work alongside engineering teams to give medical device development the structure it needs to be traceable, reviewable, and defensible - without adding process for its own sake.
The work starts by understanding where the project actually stands: what requirements exist and how they are organized, what risk documentation is in place, what gaps there are between how the device is being built and what a structured development process would expect. From that assessment, we define the right level of design control for the current stage of the product and start building or refining the artifacts that connect engineering decisions to documented evidence.
Concretely, this means producing requirements structured with clear hierarchy and verification logic, traceability matrices that link those requirements to implementation and test evidence, risk documentation that connects hazards to the specific design controls and verification activities that address them, and software lifecycle artifacts - including anomaly tracking, SOUP analysis, and cybersecurity documentation - that reflect what was actually built and how.
We are embedded in the engineering process, not separate from it. That means the documentation reflects real decisions rather than post-hoc reconstruction, and the team ends up with a design history that a reviewer, a regulatory body, or a future engineering partner can actually follow.
We also support scoping and coordination with external testing laboratories and third-party certification activities, helping teams understand what standards apply, what testing is required, and how to approach that work without being surprised later in the process.
Typical Deliverables
Interconnected
Disciplines
Need help bringing more structure to a medical device development program?
We help teams organize requirements, risks, verification, and documentation so the engineering work becomes clearer, more traceable, and easier to defend.