01
Isolation-first stackup
MOPP/MOOP zones drawn into the floorplan, with creepage and clearance to 60601-1 working voltages and reinforced barriers under the isolation transformer.
Patient-safe PCBs, designed to the standard.
Medical electronics live and die by isolation, EMC and traceability. We design PCBs to IEC 60601-1, IEC 60601-1-2 and IEC 62304 from the first stackup — not as a re-spin after the audit fails.
What medical PCB design actually requires
- IEC 60601-1 creepage/clearance: 8 mm minimum at 250 VAC mains-connected, Class I. This drives your board edge clearance, connector spacing, and layer stack — most off-the-shelf stackups don’t have enough isolation distance.
- IPC-A-610 Class 3: Medical boards require Class 3 inspection. Cold solder, lifted pads, and insufficient fillet are automatic rejects. We design and inspect to Class 3 natively.
- Conformal coating: IPC-CC-830 Type AR (acrylic) or UR (urethane) for moisture resistance. Coating thickness must be verified by cross-section on the first article.
- Patient-contact thermal: ISO 14971 risk analysis limits patient-contact surfaces to 43 °C steady-state. TRM thermal simulation gives you the data to prove compliance — before fab.
- Component traceability: Lot codes, date codes, and CoC documentation required from component level. Design your BOM for this — dual-source preferred, single-source flagged in our DFM review.
- EMC: IEC 60601-1-2 Ed4 — 8 kV contact ESD, 15 kV air discharge, 4 kV on I/O. Your layout determines whether you pass first-time or respend $15K on re-test.
8 mmcreepage at 250 V (60601-1)
2× MOPPpatient-isolation classes
Class 3IPC reliability target
ISO 13485QMS-aware design files
The deliverables.
02
Low-noise analog
Quiet reference planes, guarded inputs and Kelvin sensing for ECG/EEG/SpO2 front-ends — µV-class input-referred noise verified on the bench.
03
EMC by design
Pre-compliance review against IEC 60601-1-2 emissions and immunity: dV/dt control, return-current management, filter sizing at the IC pin.
04
DHF-ready files
Versioned stackup, impedance table, risk register and review log handed off in the format your Design History File or Technical File expects.
Built for this sector.
Standards we design to
- IEC 60601-1 (electrical safety, isolation)
- IEC 60601-1-2 (EMC)
- IEC 62304 (software lifecycle awareness)
- ISO 14971 (risk-aware layout)
- IPC-A-600 / J-STD-001 Class 3
Analog front-ends
- ECG / EEG / EMG
- SpO2, NIBP, capnography
- Ultrasound + imaging analog
- Galvanic + optical isolation
- Sigma-delta and SAR ADC layout
Reliability + assembly
- IPC Class 3 spacing and via rules
- Conformal coating + potting clearance
- Tear-drops and filled vias
- BGA escape with redundant pads
- 10-year service-life materials
A wearable ECG hitting a 1 µV noise floor.
The brief
A 24-bit ECG front-end on a coin-cell wearable was eating noise from the BLE radio and the buck converter sharing the 4-layer board.
What we did
- Re-floorplanned the analog island with a stitched guard ring and a separate quiet return back to the AFE pin.
- Moved the buck switching loop away from the AFE and gave the antenna a ground-stitched keep-out instead of a cavity.
- Re-derived the input filtering against the 60601-1-2 RF immunity envelope; added series ferrites at the electrode entry.
Outcome
Input-referred noise dropped to ~1 µV RMS in the diagnostic band — within 0.5 µV of the AFE datasheet limit — without changing the board outline.
Common questions.
Do you run 60601-1 testing yourselves?
No — we DESIGN to 60601-1 and run pre-compliance reviews of the layout. Final chamber testing is a partner referral; our design hands off so the test pass is the expected outcome, not a surprise.
Can you work inside our ISO 13485 QMS?
Yes. We deliver versioned design files, traceable design decisions and a risk-aware change log suited to your DHF or Technical File. We aren’t ISO 13485 certified ourselves — we design to support yours.
Do you default to IPC Class 2 or Class 3?
Class 2 is our default; we step to Class 3 (or 3A) when the device function, patient-contact or service life justifies it. We’ll tell you which is justified — not just upsell the strictest.
Pass the audit on the first article.
Isolation, EMC and DHF-ready files from day one. Fixed-fee band in 60 seconds.