The Problems FDA Sees That Your Team May Be Missing

The Capability Edge Live — a three-day live medical device quality and design assurance experience with Dr. John Salvato.
Tuesday 10, Wednesday 11, and Thursday 12 November 2026 · 12:00 PM Eastern daily · 45 minutes each · Free to attend · One registration covers all three sessions.

Medical device companies rarely struggle because their teams have never seen the regulations. They have procedures. They hold design reviews. They maintain risk files. They complete required training. From the inside, the system looks complete.

But completeness is not execution. A design review can satisfy the procedure without finding what will later create rework. A requirement can look acceptable until someone tries to verify it. FDA reviewers and auditors see those disconnects — usually before the organization does, and usually after the cost is already built in.

Reserve Your Seat

Free to attend. One registration covers all three sessions. You'll get the Microsoft Teams join link by email as soon as you register, plus the Design Review Quality Scorecard and the Training ROI Calculator during the event.

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Day 1 — Tuesday 10 November — What FDA Sees in Your Design File That You Don't

Why some design reviews satisfy the procedure but fail to uncover meaningful problems, how weak requirements create downstream verification issues, and where risk files can look compliant while missing the right hazards. You'll leave with the Design Review Quality Scorecard to run against a review your team has already completed.

Day 2 — Wednesday 11 November — What the Capability Gap Is Really Costing Your Company

How late-stage correction costs far more than prevention, how recurring remediation drains engineering and quality capacity, and how to translate all of it into the financial language your leadership actually budgets against. You'll leave with the Training ROI Calculator to run your own numbers.

Day 3 — Thursday 12 November — Building Capability That Holds Even When AI Writes the First Draft

What capable teams do differently, why information-based training rarely changes execution, and where AI genuinely helps versus where human judgment stays essential. The practical question is whether your team can evaluate the quality of an answer instead of accepting a confident first draft.

In the last ten minutes of Day 3, I'll explain how Design Quality Services can help your team. If that isn't relevant to you, you'll still have the full three days, the Scorecard, and the ROI Calculator.

Event Details

Tuesday 10, Wednesday 11, and Thursday 12 November 2026 · 12:00 PM Eastern daily · 45 minutes each · Live on Microsoft Teams · Free to attend · One registration covers all three sessions.

Three days to see the gaps, understand the cost, and build capability that lasts.

John Salvato, Ph.D., is the founder of Design Quality Services. Thirty years in medical device and automotive quality assurance, product development, and manufacturing; certified ISO 13485 Lead Auditor, ISO 14971, FDA Design Controls, Cybersecurity Risk Management, and IEC 62304.

Kalamazoo, Michigan · designqualityservices.com