The library.
Every shelf here started as a client question we kept answering. Now the answers are free, self-serve and open all night — tools, blueprints, AI assistants and reading for people building regulated products.
01 — SEVEN SHELVES
Pick a shelf.
Tools
Device classification, CDSCO fees and timelines, regulatory directories, FMEA and design-transfer templates.
03 MAPSBlueprints
Interactive roadmaps that turn ISO 13485, IEC 62304 and FDA wellness rules into clickable process maps.
COPILOTSAI Assistants
Custom GPTs for regulatory, SaMD and clinical-evaluation questions — assistants that did the reading.
NEW — 02 GUIDESAcademy
Free guides that explain a technology from first principles: molecular biology, cell analysis, computing and medical devices.
00 POSTSBlog
Articles and field notes from practice — regulatory, engineering and the space between.
01 BOOKBookshelf
The books we hand to founders and new engineers — a reading list that compounds.
02 NOTESField Notes
Problems we worked through in practice — what happened, why, and what it taught.
02 — WHY IT'S FREE
The tool answers the question. The next question usually needs a person. We'd rather you arrive at that conversation already knowing your device class, your fees and your timeline — it makes the fifteen minutes count.
WHEN THE TOOL ISN'T ENOUGH
Talk it through.BOOK 15 MINUTES — OR WRITE TO INFO@UNPLEX.TECH