Ruth spent eleven years assessing device submissions before going independent, which means she has seen the same avoidable failures several hundred times and has stopped being surprised by any of them.
Her value is almost entirely in sequencing. Nearly everything a device company must eventually produce — a risk file, a quality management system, clinical evaluation, usability evidence, a post-market plan — is straightforward if begun at the right moment and ruinous if begun late. She tells teams what the right moment is.
She is particularly busy with software as a medical device, where she finds a recurring mismatch: development teams accustomed to continuous deployment meeting a regulatory framework that expects a defined intended use and a controlled change process. Both positions are reasonable. Reconciling them is work, and it is better done before the first release.
She declines to write documents that describe a quality system nobody follows, on the grounds that this is the most expensive possible outcome: the cost of the paperwork with none of the benefit, and an audit finding at the end of it.
Selected projects
Named work, with a sentence of context each.
Regulatory gap analysis and resequencing
Reviewed a diagnostic company's development plan and reordered it around the evidence that would actually be required, which moved usability and clinical evaluation forward by more than a year.
Software change-control framework
Built a change-control process for a clinical decision-support product that satisfied both the regulatory framework and a development team that deploys weekly.
Pre-audit readiness review
Conducted a mock audit ahead of a certification visit, identifying four findings while they were still inexpensive to close.
Working with Ellison
A first engagement is normally a two-week gap analysis: what the intended use is, what route applies, what evidence exists, and what is missing. It is inexpensive, and it frequently changes a company's plan more than anything else it buys that year.
She works to a fixed fee for defined pieces of work and is candid when a question needs a clinician, a statistician or a lawyer rather than her.
Looking for
Device and diagnostic teams who would rather hear the awkward news in month three than month thirty.
Probably not for
Anyone seeking a document set to satisfy an investor while the underlying practice stays unchanged.
Credits and contributions
- Eleven years assessing device technical documentation at a notified body
- Lead auditor on more than sixty quality management system audits
- Trainer on clinical evaluation and post-market surveillance for industry groups