MEDICAL DEVICE ELECTRONICS MANUFACTURING

ISO 13485 Certified Medical manufacturing in Mexico or China

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Seamless Medical Device Development, From Design to Delivery

In today’s fast-evolving healthcare landscape, launching a successful medical device takes more than just a good idea, especially when it involves custom electronics. Regulatory complexity, fast-moving technology, and fragmented supply chains often stand in the way of bringing innovations to market. We’ve helped medical device companies overcome these challenges at every stage.

At SEACOMP, we specialize in the design, engineering, and manufacturing of embedded electronics for Class I and Class II medical devices. Our integrated team and global infrastructure are built to eliminate the most common production bottlenecks—especially the critical handoff from engineering to manufacturing. Whether you’re launching a new electronic product or scaling an existing one, we ensure your path to market is smooth, compliant, and on time.

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The SEACOMP Difference

  • ISO 13485 certified electronics manufacturing factories in Mexico and China
  • In-house engineering, prototyping, and NPI support for Class I and Class II medical devices
  • Medical-grade PCB assembly, firmware development, and testing
  • Seamless hand off from electronic design to mass production
  • US-based project management 

Nearshore Manufacturing for Medical Device Electronics

Accelerate your time to market with medical device manufacturing in Mexico.

For medical device companies looking to reduce lead times, avoid tariffs, and maintain high-quality standards, our Mexico facility offers the ideal solution. Located in Tijuana, just across the border from our headquarters, our ISO 13485 certified factory specializes in printed circuit board assembly (PCBA), sub-assembly, and final assembly of electronic components for medical devices.

With shorter transit times, reduced tariffs, and a skilled labor force, our Mexico location helps you simplify your supply chain and keep production agile. Plus, you’ll have seamless access to both North American and global markets—without compromising on regulatory compliance or quality standards.

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Medical Device Manufacturing Services

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Design Engineering

Optimizing Your Product Design

  • Product Development
  • Electrical Hardware Design
  • Mechanical Design
  • Embedded Software Design
  • Wireless Design & Development
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Pre-Production

Launching Your Med Device

  • New Product Introduction (NPI)
  • Tooling & Plastic Injection Molding
  • Design for Manufacturing (DFM)
  • Process Validation Tests
  • Supply Chain Optimization
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Mass Production

Scaling Your Health & Wellness Device

  • Box Build Assembly
  • PCB Assembly
  • End of Line Testing
  • Certifications
  • ISO 13485 Certified Traceability

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Medical Devices We've Brought to Market

SEACOMP supports you at every stage of the product development journey. With a proven NPI (new product introduction) process with integrated electronics engineering and manufacturing, our holistic approach consolidates efforts to deliver your vision efficiently.

Motorized Cold Therapy and Compression Device

Designed to optimize post-surgery patient recovery by reducing pain from shoulder and knee procedures. 

Our Support

  • PCB Assembly and Plasma Coating
  • Custom ICT and PCBA Functional Testing
  • 12V 1A Class II Medical Device Power Supply
  • IEC 60601 Medical Compliance
  • FCC EMC Certification

IoT Connected Toothbrush

Thanks to its four sonic-powered customizable modes, long-lasting battery, and gum health setting, this Class I electric toothbrush empowers users to develop great brushing practices.

Our Support

  • Custom Charging Stand with 5W Wall Adapter
  • Test Fixture Development 
  • Mechanical and Electrical DFM
  • Tooling Design 
  • IPX7 Test and Validation Plan 

Wearable Continuous Glucose Monitoring Sensor

This discreet and wearable Class II smart sensor provides real time readings without the need for scanning or fingersticks.

Our Support

  • Medical Wall Adapter
  • Custom Braided USB Charging Cable
  • IEC 60601 Medical Compliance
  • Global Certifications
  • Product System Aesthetics

PARTNERSHIPS BUILT TO LAST

We believe that happy people make better products, and how we do business reflects this. Strong relationships are the foundation of SEACOMP, so you can confidently trust that your IP is protected by an established manufacturer, helping you build opportunities to scale your product into the future.

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Case Study: Nearshoring Medtech

Read how Activbody, an innovative medtech company improving the outcome of physical therapy, came to us to nearshore their latest device at our ISO 13485 certified factory in Mexico.

Read the Case Study

SEACOMP CERTIFICATIONS

Your product needs to meet high standards, and we understand this expectation. Beyond standard safety and compliance certifications, we go the extra mile to help your product excel in quality and reliability, starting at the factory floor.

ISO 13485:2016

Certified

ISO 9001:2015

CERTIFIED

FDA Registered

MANUFACTURER
SEACOMP