Medical Turnkey PCB Assembly

PCBMay’s turnkey PCB assembly services for medical devices are backed by an ISO 13485 quality system. We manage key manufacturing processes from component sourcing and PCB fabrication to high-precision SMT and THT assembly.
• ISO 13485 Certified Quality System
• Traceable Component Sourcing & BOM Support
• No Minimum Order Quantity from 1 Piece
• SMT, THT & Mixed Technology Assembly
• HDI, Flex & Rigid-Flex PCB Support
• 01005 Components & 0.2 mm Fine-Pitch BGA

Medical Prototype PCB Assembly
Certifications
What is Medical Prototype Assembly
introduction

What is Medical Turnkey PCB Assembly?

A medical turnkey PCB assembly is a one-stop solution where the manufacturer takes care of end-to-end production.  The process includes PCB (printed circuit board) fabrication, parts procurement, surface mount and through-hole assembly, and final testing. Instead of managing multiple vendors and juggling complex supply chains, you rely on a single trusted partner. This simple process means less delay in the supply chain, less internal cost, and constant, strict medical standards from raw materials to the finished product.

Products

Benefits of Medical Turnkey PCB Assembly

  • Complete Turnkey Service from BOM to Finished PCBA
  • Full Manufacturing Traceability
  • Streamlined Supply Chain & Early Error Detection
  • Lower Procurement and Project Management Costs
  • Faster Prototype-to-Production Transition
Complete Turnkey Service from BOM to Finished PCBA
A complete turnkey solution covers the entire PCBA manufacturing chain, including PCB fabrication, component sourcing, SMT/THT assembly, IC programming, functional testing, and conformal coating when required. By integrating these processes with one manufacturing partner, you can simplify supplier management, reduce communication gaps, and maintain better control over production quality.
Full Manufacturing Traceability
Streamlined Supply Chain & Early Error Detection
Lower Procurement and Project Management Costs
Faster Prototype-to-Production Transition
Why Choose Us

Why Choose PCBMay?

  • ISO 13485 Certified Manufacturing

    ISO 13485 Certified Manufacturing

    You get support for compliance with the highest global safety and precision standards. Our certified management system secures your medical project and ensures reliable functioning of your important medical electronics.

  • No Minimum Order Quantity

    No Minimum Order Quantity

    You can order a single unit to test your electronic concepts. Our flexible low-volume assembly system fully supports your engineering timeline without forcing massive up-front costs.

  • Free DFM/DFA Check Support

    Free DFM/DFA Check Support

    You eliminate expensive engineering mistakes before a single board is built. This complimentary layout analysis catches component placement and clearance errors early, saving your timeline from costly production delays.

  • Reliable Component Sourcing & BOM Optimization

    Reliable Component Sourcing & BOM Optimization

    You receive fully traceable, high-grade parts from our trusted global supply network. This comprehensive bill of materials optimization helps identify obsolete or at-risk components and recommends suitable alternatives when available. Securing a seamless path to your volume manufacturing.

Specs

Technical Specifications


Order Quantity ≥1PCS
Service Options Full Turnkey PCB Assembly, Partial Turnkey, Component Sourcing, PCB Fabrication
Board Type Rigid PCB, Flexible PCB, Rigid-Flex PCB, Metal Core PCB
Assembly Types Surface Mount Technology (SMT), Through-Hole Technology (THT), Mixed Technology
Component Sourcing Turnkey (All components sourced by us), Trusted Global Supply Network
Mounting Accuracy ±0.035mm(±0.025mm) Cpk≥1.0 (3σ)
Min Package 01005 (0.4mm*0.2mm)
BGA Package Down to 0.2mm pitch with fine-pitch X-ray inspection
Testing & Validation Automated Optical Inspection (AOI), X-Ray, Flying Probe, Functional Testing (FCT), FAI
Conformal Coating Acrylic (AR), Silicone (SR), Polyurethane (UR), UV
Certificate ISO 13485, ISO 9001:2015, IPC Class 3, RoHS, REACH
Medical Prototype PCB Assembly Sample
Capabilities

Our Medical Turnkey PCB Assembly Process

Step 1: Engineering Review & DFM/DFA Analysis
You receive a comprehensive review of your design files and BOM before physical manufacturing begins. The first step checks your component footprints, clearance, and orientation for manufacturability and assembly problems.
Step 2: BOM Verification, Component Sourcing & IQC
Step 3: SMT & THT Assembly
Step 4: Inspection & Functional Testing
Step 5: Packaging & Global Delivery
Quality Control

Files Required for Turnkey PCB Assembly

  • BOM (Bill of Materials)

    BOM (Bill of Materials)

    The bill of materials or BOM includes part numbers, manufacturers, parameters, etc., that is needed to obtain components and build the PCB product.

  • Gerber Files

    Gerber Files

    The standard design files for PCB manufacturing. The files will contain data for the copper layers, solder mask layers, screen printing, drill holes, component placements notations, and other relevant physical data for the board.

  • Pick-and-Place (Centroid) File

    Pick-and-Place (Centroid) File

    Also known as XY Files, these provide the exact position and orientation of each electronic component on the PCB. They include the component reference designator and package type to precisely guide the automated pick-and-place machines during the assembly step.

  • Additional Manufacturing Files

    Additional Manufacturing Files

    Additional Manufacturing Files: Depending on the complexity of your board, other important files may be needed.

    · Test Specifications / Functional Test Documents: If functional testing is required, you may need to provide test specifications, testing procedures, acceptance criteria, or related documents. These files help our engineering team develop or perform appropriate verification processes to confirm your PCBA meets the required electrical and functional performance.
    · Assembly Drawings: Assembly drawings provide visual instructions for PCB assembly, including top and bottom component locations, reference designators, polarity information, and special handling requirements.

Our Medical Prototype Assembly Process
Specs

Turnkey PCB Assembly vs Consignment PCB Assembly

The choice of manufacturing type for medical electronic products depends on your internal resources, supply chain, project requirements, delivery times, and other factors. The main types are Turnkey PCB Assembly and Consigned PCB Assembly.

Turnkey Assembly: The manufacturer manages most or all production activities, including component sourcing, PCB fabrication coordination, assembly, inspection, and testing.

Consigned Assembly: The customer provides the required components while the manufacturer focuses on PCB assembly, inspection, and testing processes.

As a professional full-service PCB assembly manufacturer, PCBMay is committed to providing our customers with one-stop services ranging from component procurement to PCB production and assembly. We help you accelerate your medical device R&D process. Send us your Gerber files and BOM today to receive a quick quote and evaluation.

Case Study

Medical Prototype PCB Assembly Cases

  • Automated External Defibrillator (AED) Turnkey Assembly
    Automated External Defibrillator (AED) Turnkey Assembly Automated External Defibrillator (AED) Turnkey Assembly

    Automated External Defibrillator (AED) Turnkey Assembly

    Managed component sourcing and turnkey assembly for AED control boards requiring high reliability and strict quality control. Implemented IPC Class 3 manufacturing processes, electrical testing, and component traceability to support consistent production quality.

  • PCBA for Ultrasound Diagnostic Equipment
    PCBA for Ultrasound Diagnostic Equipment Point-of-Care Blood Analyzer Board Assembly

    Point-of-Care Blood Analyzer Board Assembly

    Delivered fully assembled multilayer diagnostic boards. We optimized the bill of materials for long-term availability and achieved optimal trace accuracy, drastically accelerating the medical device's market launch.

  • Robotic Surgical Controller PCBA
    Robotic Surgical Controller PCBA Robotic Surgical Controller PCBA

    Robotic Surgical Controller PCBA

    Created a turn-key solution for complex multi-board surgical controllers. With an advanced 3D X-ray inspection that enables a zero-defect process for high-density BGA placements.

  • Wireless Pulse Oximeter Turnkey Production
    Wireless Pulse Oximeter Turnkey Production Wireless Pulse Oximeter Turnkey Production

    Wireless Pulse Oximeter Turnkey Production

    Provided complete component sourcing and ultra-compact SMT assembly for wearable wireless oximeters. An extensive and affordable mass production run was accomplished within the ISO 13485 medical requirements.

  • Portable Ultrasound Module
    Portable Ultrasound Module Portable Ultrasound Module

    Portable Ultrasound Module

    Built advanced, high-density diagnostic assemblies. Managed difficult component procurement during global shortages and implemented exceptional thermal management solutions for continuous clinical use.

Faqs

Frequently Asked Questions

Our Medical Turnkey PCB Assembly FAQ addresses essential questions regarding your manufacturing requirements. We cover our capabilities for complex medical electronics, supply chain management, assembly timelines, rigorous quality inspection protocols, and our capacity to scale from initial builds to production batches. For every medical device project, we guarantee precision-focused, medical-grade assembly standards.

1. What Files Are Typically Required to Get a Turnkey PCBA Quote?

For an accurate estimate, turnkey providers typically ask for a standard set of electronic files. This includes Gerber files for manufacturing the bare circuit board, a detailed Bill of Materials (BOM) that lists all component part numbers, and Centroid (or pick-and-place) data, which specifies the X-Y coordinates and rotation for each component on the board.

2. What Factors Influence the Lead Time of a Turnkey PCBA Project?

Lead time is probably the most variable element of turnkey PCBA and can be affected by many factors.  The most significant factors are the procurement time for all components on the BOM (especially for parts with long lead times or those that are hard to find), the complexity of the PCB fabrication, the assembly process itself, and the extent of required quality testing.

3. Do You Provide Quick-Turn Services for Turnkey Medical Projects?

Yes. We can accelerate parts procurement and prioritize assembly for you by utilizing our global supply chain network. Standard lead times for urgent medical prototypes can be reduced to just a few days, depending on immediate BOM availability.

4. How Do You Guarantee the Quality and Safety of Turnkey Medical Boards?

We manufacture under a strict ISO 13485-certified quality management system specifically designed for medical devices. Depending on project requirements, PCBAs can undergo AOI, X-ray inspection, Flying Probe Testing, and Functional Testing to verify assembly quality and electrical performance.

5. Do You Require a Minimum Order Quantity for Medical Turnkey Runs?

No. We maintain a no Minimum Order Quantity (≥1 PCS) policy. We are entirely equipped for single-unit engineering validations, low-volume pilot runs, and smooth high-volume mass production.

6. What Is PCB Panelization and How Does It Affect Assembly Costs?

Panelization involves grouping multiple identical PCBs onto a single, larger board array. This maximizes the speed and efficiency of automated SMT placement machines, which significantly lowers your per-unit labor and manufacturing costs during production.

7. Can You Handle Complex Medical Layouts Like Fine-Pitch BGAs in A Turnkey Run?

Yes. Our advanced automated SMT lines are built for high-precision layouts. We reliably source and assemble miniature 01005 components and ultra-fine 0.2mm pitch BGAs, using X-ray inspection to verify BGA solder joint quality.

8. When Should You Choose a Full Turnkey Solution Instead of a Partial Turnkey?

Choose a full turnkey solution when you want to eliminate internal procurement workloads, avoid supply chain delays, and accelerate your time-to-market. If you already have stock of highly specialized or difficult-to-source medical components, that is when partial turnkey is recommended.

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