KEYSTONE MEDICAL DEVICE PARTNERS
Many device recalls trace back to a scenario nobody tested for.
Unexpected user interaction. Abnormal system behavior. The FDA publishes the list, and it updates weekly.
Requirements-based testing confirms you built what you specified.
Risk ID finds what you did not specify, because nobody expected it.
What you end up with: submission-ready evidence, and no surprises after release.
Built for modern medtech.
Connected devices, SaMD, wearables, drug delivery, hospital systems, diagnostics, and patient-facing platforms.
Real use is not clean use.
Clinicians transport patients mid-procedure. They repeat steps. They override assumptions, respond to alarms while managing another alarm, and make reasonable decisions under pressure that nobody wrote a requirement for.
Software, sensors, connectivity, accessories, and the user interface can each behave correctly in isolation while the combined system creates risk in the clinical workflow.
Those patterns appear repeatedly in FDA recall records. Standard verification is not built to find them.
How Risk ID works
01 — Find the blind spots.
We put your clinical SMEs, product users, support, R&D, and human factors people in one room and work through a core workflow. Every attendee contributes scenarios. The room fills the whiteboard.
02 — Prioritize and convert.
Scenarios are ranked by impact vs probability. The high-impact ones become test cases. The rest are already covered by requirements-based testing.
03 — Connect risk to evidence.
Every scenario ties back to a design control. Risk, requirement, test case, objective evidence, result, residual risk. Your team can defend it in a review.
Expertise across the entire lifecycle.
If any of this is on your desk right now
A launch date that has not moved while the software has. Field complaints that point at scenarios nobody tested. A submission where you cannot show how you decided test coverage was sufficient. A team being pushed to use AI on a regulated project, without a defined boundary around it.
Two we can talk about
Clarify Medical. Software QA and verification support across a connected device and its physician and patient portal, released as SaMD. 2017 Successful product release.
Synthetic Genomics. Brought their DNA instrument onto a GMP workflow, supporting the business unit through to sale. 2018 Business Unit Sold.
Start with your own test strategy, not a sales call.
Seven questions. You score yourself. Nothing is sent to us and nobody calls you.
If the score comes back low in a place that worries you, a paid protocol assessment goes deeper on one product line. The fee credits toward the engagement if you proceed.
Ready to move your medical device forward?
Tell us where your program stands, and we’ll help identify the clearest path forward.
Keystone Medical Device Partners 