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.
Written from thirty years of design reviews, submissions, remediation projects, and inspections — the ones that went well and the ones that didn't. Every issue brings one failure pattern that repeats across device companies, the reasoning behind it, and a tool you can use the same week.
Start with the most recent issue: What Poor Technical Capability Costs Device Teams