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Insights

First-hand notes from the practice.

Design controls, the QMSR transition, and where AI actually helps in regulatory work — written by the engineer doing the work, not a content team.

Diagram: the QSR's fifteen subparts collapsing into the QMSR's two subparts, with design controls moving to ISO 13485 Clause 7.3
Featured Regulatory

The QMSR is not a rebrand: what actually changed in design controls

FDA's QMSR took effect February 2, 2026. The old fifteen-subpart QSR collapsed to two — here are the five deltas hiding inside "substantially similar," and where they break SOPs.

10 min read
Diagram: a flat FMEA row becoming a traceable design-FMEA record that links failure modes to design inputs, verification and risk controls
AI · Design controls

Populating a design FMEA with AI

6 min read
Matrix comparing what AI-native design-control platforms automate versus what still needs a human regulatory reviewer
AI platforms

What AI-native design control platforms actually automate

8 min read
Diagram tracing a design requirement's lineage from user need through design input to the verification activity that confirms it
Design controls

Reviewing a grant proposal for design control gaps

7 min read
Diagram clustering a university patent portfolio into platform, standalone and outlier technologies
IP · Tech transfer

What a university patent portfolio assessment actually involves

7 min read
Five-stage ISO 13485 Clause 7.3 design-control flow with its ASTM and ISO standards battery
Design controls

Design controls for a Class II implant, done right

8 min read
Diagram of a living document-workflow procedure loop, refined through repeated engagements
AI · Process

Teaching an AI assistant your document workflow

7 min read
Have a device in this territory?

Bring the questions. I'll bring twenty years.

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