PCBMay

Medical Grade
ENIG / ENEPIG Plating

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Certifications

introduction

What is Medical Prototype Assembly?

It is the process of building small quantities of printed circuit board assemblies for testing, validation, and product development. Before moving into mass production, medical device manufacturers use prototypes to verify functionality, evaluate performance, and identify potential design improvements. Prototype assemblies play a critical role in reducing development risks, accelerating product launches, and ensuring compliance with stringent healthcare industry requirements.

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Products

Quality Standards & Compliance

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ISO 13485 Quality Management11111

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IPC Class 3 Manufacturing

RoHS and REACH compliant

Inspection and Testing Records

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Benefits

Key Benefits of High-TG FR4

Improved Heat Resistance

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Reduced Delamination Risk

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Better Dimensional Stability

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Improved Heat Resistance

Haec subinde Constantius audiens et quaedam referente Thalassio doctus, quem eum odisse iam conpererat lege communi, scribens ad Caesarem blandius adiumenta paulatim illi subtraxit.
Reduced Delamination Risk

Harum trium sententiarum nulli prorsus assentior. Nec enim illa prima vera est, ut, quem ad modum in se quisque sit, sic in amicum sit animatus.
Better Dimensional Stability

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Specs

Technical Specifications

Application	Medical device
Size (DxL)	85mm x 38mm
Assembly Types	SMT and DIP
Layers	8-Layer
Finish	Immersion gold
BGA Package	BGA 0.2 pitch
Certificate	ISO 9001:2015 \| ISO 13485 \| UL

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How to choose

Our Medical Prototype Assembly Capabilities

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Fast Prototyping Turnaround

Our rapid prototyping service supports fast delivery of medical PCBs, helping engineers validate designs quickly, reduce development cycles, and accelerate time-to-market for innovative medical equipment solutions.

High Precision PCB Assembly

We deliver high-precision medical prototype PCB assembly with strict process control, ensuring accurate component placement, stable electrical performance, and reliable operation for critical healthcare applications and devices.

Strict Quality Control Standards

We implement rigorous quality inspection throughout medical prototype assembly, including SPI, AOI, and functional testing, ensuring compliance with medical industry standards and high reliability for patient safety.

Advanced SMT Technology Support

Using advanced SMT production lines, we assemble complex medical prototype PCBs with fine-pitch components, multilayer designs, and high-density layouts, ensuring precision, consistency, and superior manufacturing performance.

Specs

PCB Requirements for Medical Devices

High Reliability & Stability

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Controlled & Repeatable Processes

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Thermal & Mechanical Resistance

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Production Traceability

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Processes

Our Medical Prototype Assembly Process

At PCBMay, our medical prototype assembly process is designed to ensure precision, reliability, and compliance at every stage. We begin with a thorough design review (DFM) to optimize manufacturability and identify potential issues early. Next, we carefully handle component sourcing, selecting high-quality, fully traceable materials that meet stringent medical standards. During prototype assembly, our team utilizes advanced SMT, THT, BGA, and rigid-flex assembly techniques to build accurate and functional prototypes.

Each unit undergoes rigorous inspection and testing, including AOI, X-ray, and functional verification, to guarantee performance and reliability. Finally, prototypes receive final verification and are delivered with detailed reports, enabling design validation, iteration, and a smooth transition to volume production.

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industries

Industries For All Your Need

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Case Study

Medical Prototype Assembly Cases

Portable Patient Monitoring Device

Successfully assembled reliable prototype PCBs for portable patient monitors, ensuring precision, rapid turnaround, stable performance, and regulatory readiness.
Wearable ECG Monitoring System

Manufactured high-density prototype assemblies for wearable ECG devices, delivering accurate signal integrity, compact design, and dependable operation.
Ultrasound Diagnostic Equipment

Built complex multilayer prototype assemblies for ultrasound systems, achieving exceptional quality, reliable functionality, fast delivery, and consistent performance.
Smart Infusion Pump Controller

Produced precision PCB prototypes for infusion pump controllers, supporting strict quality requirements, functional testing, and accelerated product development.

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Faqs

Frequently Asked Questions

Our Medical Prototype Assembly FAQ addresses common customer concerns, including supported device types, handling of complex PCBs, fast prototype turnaround, strict quality control, and scalability from single prototypes to small batch production, ensuring reliable medical-grade assemblies.

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1. What is medical prototype assembly?

Medical prototype assembly is the process of building small batches of PCBAs for testing, validation, and design verification before mass production in medical device development.

2. What types of medical devices do you support?

We support a wide range including patient monitors, diagnostic equipment, portable devices, therapeutic systems, wearable electronics, and laboratory testing instruments.

3. Can you handle complex PCB designs?

Yes, we specialize in complex designs including HDI, BGA, fine-pitch components, rigid-flex boards, and mixed technology assemblies for demanding medical applications.

4. Do you provide fast prototype turnaround?

Yes, we offer fast prototype assembly services to help customers accelerate development cycles, validate designs quickly, and reduce overall time-to-market.

5. How do you ensure quality and reliability?

We use strict quality control processes including AOI inspection, X-ray testing, functional testing, and full process traceability to ensure consistent medical-grade reliability.

6. Can you support both small and larger prototype runs?

Yes, we support single prototype builds, small batch production, and scalable transition to volume manufacturing based on project requirements.