Case A
The QMS that could not survive FDA submission
- Company
- Silicon Valley medical device company we know intimately, 1 to 50 employees, ~10 years in.
- Speaks loudest to
- VP Quality, COO
- Lesson
- A $50/month QMS in year one becomes a six-figure migration plus a 12-month GTM delay in year ten, when the company can least afford it.
Challenge.
They picked their first QMS from a smaller QMS startup in year one to save money. As the company prepared FDA submission, the QMS could not produce the audit trail the company’s Quality and Regulatory teams needed. The path forward was a migration, mid-submission, to an established validated QMS.
Solution (what we now do).
A Day-Zero Diagnostic in year one would have flagged the QMS choice immediately. We help select a medical-device-grade QMS sized to a 1 to 100 employee company but built on a vendor that scales. Quality owns validation, regulated records, and QMS execution. We help make sure the company-side IT environment supports that work.
Result.
- > $200,000
- Migration cost
- 12 months
- Migration duration
- ~12 months
- Of GTM delay during a live FDA submission
What this means for you.
If your QMS today is the cheapest one you found in your first six months, ask Quality whether it will produce the trail an auditor expects.