Medical PCB Manufacturer — ISO13485 Certified
Riching PCB is an ISO13485-certified medical PCB manufacturer in Shenzhen. Rogers, PTFE and FR4 materials for MRI RF coils, ultrasound transducers, patient monitoring and surgical systems. IPC Class 3 on request. Full material traceability. ENIG and ENEPIG surface finish for biocompatibility. 2–50 layers including flex and rigid-flex. No MOQ.
Table of Contents
ISO13485
certified
medical device QMS
MRI RF coil
Rogers in stock
1.5T / 3T / 7T
Class 3
IPC on request
full traceability
No MOQ
From 1 board
rigid · flex · rigid-flex
Medical PCB Requirements — and How We Meet Them
| Medical Requirement | What It Means for PCB | Riching PCB Approach |
|---|---|---|
| ISO13485 certification | QMS specific to medical devices — covers design control, process validation and CAPA | Certified — documentation available on request |
| Full material traceability | Every material lot trackable to the finished board | Lot records maintained per ISO13485 |
| IPC Class 3 | Highest reliability — required for life-sustaining devices | On request — specify on order |
| Biocompatible surface finish | ENIG / ENEPIG — no lead for patient-contact boards | ENIG standard; ENEPIG available |
| Ionic contamination test | Low ionic residue for implantable and patient-contact boards | Cleaning process available, test report on request |
Medical PCB Applications
| Application | Frequency / Material | Key Requirement |
|---|---|---|
| MRI RF coil (1.5T / 3T) | 64–128 MHz / Rogers RO4350B or PTFE | Low loss, dimensional accuracy, biocompatibility |
| MRI RF coil (7T ultra-high field) | 298 MHz / RO4350B / RO3003 | Very low Df, tight impedance, IPC Class 3 |
| Ultrasound transducer array | 1–15 MHz / Rogers / FR4 Hi-Tg | Fine pitch, flex / rigid-flex |
| Patient monitoring wireless | 2.4GHz / 5GHz / FR4 Hi-Tg | Controlled impedance, halogen-free |
| Surgical robot RF interface | Sub-6GHz / RO4350B | Biocompatible surface finish, full traceability |
| Implantable device antenna | MICS 402–405 MHz / Rogers | Ultra-low loss, miniaturized, IPC Class 3 |
| X-ray / CT detector interface | High-speed digital / Nelco / FR4 | Controlled impedance, fine-pitch HDI |
MRI RF Coil PCB — The High Frequency Requirement
MRI RF coil PCB operates at Larmor frequency — 64MHz for 1.5T systems, 128MHz for 3T, and 298MHz for 7T ultra-high field. At these frequencies, substrate loss directly affects coil Q-factor and signal-to-noise ratio. Rogers RO4350B (Df 0.0037) and RO3003 (Df 0.0010) are both used depending on field strength and coil geometry. Riching PCB stocks both grades — no procurement delay for prototype iterations.
For a full discussion of material selection for MRI RF coil PCB, see high frequency PCB for medical devices.
Manufacturing Capabilities for Medical PCB
- Layer count: 2–50 layers
- Board types: rigid, FPC flex, rigid-flex, aluminum base
- Materials: Rogers RO4350B, RO3003, RT5880, FR4 Hi-Tg, Nelco, halogen-free grades
- Min trace/space: 3mil/3mil standard, 2.5mil/2.5mil advanced
- Min drill: 0.2mm mechanical, 0.1mm laser
- Impedance: ±10% standard, ±5% TDR available
- Surface finish: ENIG standard, ENEPIG for wire bonding / biocompatibility, immersion silver
- IPC Class 2 standard, IPC Class 3 on request
- Special processes: blind/buried via, rigid-flex, backdrill, embedded passive, step gold finger
- Assembly: SMT turnkey available with AOI and X-Ray inspection
ISO13485 Documentation
ISO13485 certification covers the full PCB manufacturing process including incoming inspection, process validation, change control, CAPA and outgoing quality control. For medical device programs requiring supplier qualification or design history file (DHF) documentation, the following are available on request:
- ISO13485 certificate
- Material certificates and lot traceability records
- Process qualification records
- IPC Class 3 inspection reports
- Ionic contamination test reports (on request)
How to Order
- WhatsApp: +86 13760473650
- Send: Gerber zip + NC drill + stackup drawing
- Specify: IPC Class, surface finish, traceability / documentation requirements
- DFM review: 4–8 hours
- No MOQ. From 1 board.
Medical PCB Manufacturer — ISO13485 Certified, Shenzhen
MRI RF Coil · Ultrasound · Patient Monitoring
ISO13485 · IPC Class 3 · Rogers PTFE In Stock
Send Gerber + stackup drawing. DFM review within 4–8 hours.
ISO13485 and traceability documents available on request.
DFM review within 4–8 hours
Request a PCB Quote
Upload your Gerber ZIP file and project requirements. Our engineering team will review your PCB material, stackup, impedance needs, surface finish, and production quantity before quoting.
Please prepare:
- Gerber files in ZIP format
- PCB material or stackup requirements
- Controlled impedance notes if available
- Prototype or batch production quantity