SPEC PUZZLE · MED

Medical device spec

18 specs · FDA QMSR (Feb 2026) + EU MDR drive class evidence

SPEC PUZZLE · WHY IT EXISTS

Tired of reviewing every symbol in a contract?

33% of B2B orders ship wrong because spec drift hides in walls of text. Same data, two views — guess which one your eye reads in 250 ms.

① TEXT · WHAT YOU GET TODAY

SPEC SHEET12 ROWS · ABBREVIATED
CONTRACTPCB-2026-00042-A
PRODUCTCOPPER CLAD LAMINATE FR-4
GRADETg170 · Td330 · CTI 175
CONSTRUCTION4-LAYER · IPC-4101/126
COPPER WEIGHT1 oz / 35 µm
GLASS STYLE7628 × 4 ply
Dk @ 1 GHz4.4
PEEL STRENGTH≥1.4 N/mm
HALOGENfree · IEC 61249-2-21
IPC CLASS2
SURFACE FINISHENIG 50µ" / 200µ"
SOLDER MASKLPI green · Taiyo PSR-4000

~10 seconds to scan. Most buyers miss the drift.

same contract

② VISUAL · WHAT WE REPLACE IT WITH

PSG-0IWT-O500-5MOP

250 ms. Pre-attentive vision did the read.

IN YOUR DEAL

draft RFQ›supplier quote›sign›countersign›photo verify›audit

one signature · six surfaces

Try it with your own spec. Paste a sheet, drop a photo, or fill the form — the puzzle assembles in real time.

TRY THE PUZZLE →

⚡ PASTE A SPEC SHEET · AI FILLS THE PUZZLE

Drop in a free-text spec from a PDF, email, or supplier datasheet. Claude Sonnet 4.6 normalizes units, reconciles bilingual values (e.g. 1/4" ↔ 6.35 mm), and fills the puzzle below with per-axis confidence. Confidence below 80% is flagged as unverified.

SPEC COMPLETENESS

8 MISSING · 0 MISMATCH

18 specs · 8 required

Core

Device type
MISSING

FDA class
MISSING

MDR class
MISSING

Pathway
MISSING

QMS
MISSING

Sterilization
MISSING

Biocompat
MISSING

Material
MISSING

Sterility

SAL
UNVERIFIEDopt.

Packaging
UNVERIFIEDopt.

Shelf life
UNVERIFIEDopt.

Manufacturing

Cleanroom
UNVERIFIEDopt.

UDI
UNVERIFIEDopt.

Traceability
UNVERIFIEDopt.

Tolerance
UNVERIFIEDopt.

Quality

Endotoxin
UNVERIFIEDopt.

Particulate
UNVERIFIEDopt.

Dossier
UNVERIFIEDopt.

VALIDMISSINGMISMATCHUNVERIFIED

FILL THE SPEC · LIVE-VALIDATED

⚡ AUTOFILL · PASTE YOUR SPEC

Core

DEVICE TYPEMISSING· implant / instrument / disposable / diagnostic / wearable / capitalFDA CLASSMISSING· I / II / IIIMDR CLASSMISSING· EU MDR I / IIa / IIb / IIIPATHWAYMISSING· 510(k) / PMA / De Novo / CE MDR / PMDAQMSMISSING· ISO 13485 · FDA QMSR (21 CFR 820)STERILIZATIONMISSING· EtO / gamma / e-beam / steam / VHP / X-ray / non-sterileBIOCOMPATMISSING· ISO 10993 panel + contact category (surface/implant)MATERIALMISSING· implant-grade Ti / PEEK / silicone / USP Class VI polymer / SS 316L

Sterility

SAL(optional)UNVERIFIEDPACKAGING(optional)UNVERIFIEDSHELF LIFE(optional)UNVERIFIED

Manufacturing

CLEANROOM(optional)UNVERIFIEDUDI(optional)UNVERIFIEDTRACEABILITY(optional)UNVERIFIEDTOLERANCE(optional)UNVERIFIED

Quality

ENDOTOXIN(optional)UNVERIFIEDPARTICULATE(optional)UNVERIFIEDDOSSIER(optional)UNVERIFIED

WHY THESE SPECS MATTER

Wrong sterilization = device ineffective or unsafe; wrong device class = wrong submission pathway (510(k) vs PMA) and months of rework. ISO 13485 + ISO 10993 biocompatibility gate every regulated build.

When the puzzle is complete, post the RFQ.

All verified specs flow into a structured RFQ with the spec snapshot frozen at submission.

Post RFQ with this spec →