Independent design assurance · Minneapolis, MN
A risk-based design process that starts with the user. Usability, safety, and efficacy are built in from the first user need — so the path to regulatory approval is set from the start, not reconstructed at the end.
Services
Most programs don't fail on the bench. They fail on paper — a protocol that can't support its own acceptance criteria, a risk file that doesn't trace, a report an FDA reviewer can't follow. That paper is the job.
Protocols, execution oversight, and reports that state what was tested, why the sample size holds, and what the statistics actually show.
Hazard analysis, use-related risk, design and process FMEAs, and benefit-risk conclusions built to ISO 14971 — and kept alive through change.
Requirements that can be tested, traceability that closes, and design reviews with real decisions in the minutes. Remediation when a DHF grew up without them.
Fixtures, procedures, and measurement-system analysis for the things catheters have to prove: tensile, torque, kink, burst, trackability, coating integrity.
Which tests, which standards, which predicate — decided before the bench work starts. Support drafting the performance sections and answering deficiencies.
Independent review of controlled documents before release: cross-references checked, numbers reconciled, redlines delivered as tracked changes with a findings memo.
How an engagement runs
Every engagement has a written scope, a named deliverable list, and a release step. You always know what's in, what's out, and what "done" means.
A short discovery call, a look at the current DHF, and a fixed-scope proposal with deliverables listed by document number.
User needs, design inputs, risk, and the regulatory test strategy aligned before anything goes to the bench. Sample sizes and statistics justified up front.
Protocols authored, execution supported, data reviewed against the datasheets — not the summary — and deviations dispositioned in writing.
Reports, risk file, and trace matrix QC'd independently and delivered ready for your change order, your auditor, and your reviewer.
Designed around the people who use the device and the places they use it. Use-related risks are found early and designed out — not discovered in a summative study.
Risk management drives the design rather than documenting it afterward. Every hazard traces to a control, and every control is verified.
The device has to do what the user needs, every time. Performance is defined in measurable design inputs and proven through verification and validation.
Experience
Nick Ellering brings more than 20 years of medical-device development, helping teams earn dozens of FDA 510(k) clearances, PMA approvals, and international regulatory approvals.
That experience was earned building devices, not just reviewing them. It shapes how every program starts: with the user. Clinicians, patients, and the environment they work in define the user needs. Those needs become measurable design inputs. Those inputs drive design outputs that can be built, tested, and traced all the way back to the person the device is for.
Risk analysis runs alongside every step, so usability, safety, and efficacy are designed in — and the evidence a reviewer needs exists the moment the design does.
Contact
A DV report due before a submission, a risk file that predates the current design, a DHF that needs to survive an audit — send a few lines and you'll get a straight answer on whether and how we can help, usually within one business day.