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Medical PCBA Prototype & Mass Production for Vital Signs Monitoring Device

Industry: Medical Device / Wearable Health
Scope of Service: DFM / DFT | Rigid-Flex PCB | SMT Assembly | Low-Noise Signal Test | Full QC Documentation
Technical Highlights: High-precision analog front-end, low-noise circuit, rigid-flex PCB, biocompatible surface finish, ISO 13485 quality control

Final Outcomes & Measurable Value

Signal Performance: The low-noise design achieved clean ECG waveform acquisition, and the rigid-flex board passed the bending cycle test.
Document Support: Complete batch manufacturing records available for the customer’s ISO 13485 audit.
NPI Progress: Wearable PCBA prototypes delivered successfully, supporting the customer’s clinical validation phase.

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Client Background & Initial Challenges

A European medical device company is developing a portable wearable ECG monitoring device for home health screening. The device uses a small rigid-flex PCBA to fit the wearable housing.

Key Challenges

Technical: High-precision weak bio-signal acquisition, circuit noise suppression, and repeated bending durability of the flexible board.

Quality: Medical traceability and complete manufacturing records required for ISO 13485 audit.

Manufacturing: Assembly of miniature components on a rigid-flex substrate.

MTI End-to-End Solution

DFM & Signal Integrity Review: Analog circuit layout optimization to reduce EMI noise, with separated analog and digital ground planes to protect the ECG signal.
Rigid-Flex PCB Fabrication & Assembly: Special process for rigid-flex board and precise SMT placement of tiny analog components.
Special Testing: Low-noise signal measurement, repeated bending reliability test, and full functional verification.
Medical-grade QC: Recording every production step with component lot traceability and generating inspection documents for medical certification submission.
Protective Packaging: Anti-static packaging suitable for medical components.

Final Outcomes & Measurable Value

Visual Proof & Testimonial

Client Quote: “Bio-signal noise was critical for our wearable ECG device. MTI’s analog layout advice and strict medical QC helped us move forward smoothly.”

— 03 · MTI Engineering Approach

Redesigning the hardware architecture

Our engineering team focused on:

Medical PCBA Prototype & Mass Production for Vital Signs Monitoring Device 6

Nordic BLE module integration

Our in-house designers and engineers have produced countless great designs for customers from different

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Low-power circuit optimization

Choose us, and we promise to do everything needed to ensure a successful and satisfactory working

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Sensor interface design

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PCB layout improvement

ustomers choose us because we provide leading technology, deliver unmatched products and services.

Component selection according to production requirements

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