The Capability Edge
A monthly newsletter for design, quality, and regulatory professionals who want to close the gap between knowing the regulation and implementing it.
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Not regulatory summaries. Not news roundups.
What actually shows up in FDA inspections and notified body audits, why it keeps showing up, and what well-functioning teams do differently.
We focus on
One failure pattern that repeats across device companies
The reasoning behind it
A tool you can use the same week
Written from thirty years of design reviews, submissions, remediation projects, and inspections — the ones that went well and the ones that didn't.
What Poor Technical Capability Costs Device Teams
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.