Medical Device Electronics Manufacturing
The success of your medical device relies on so much more than just being a great idea. It requires a high level of quality control, in-field reliability, and meeting industry-specific certifications to give your customers confidence in your product. These critical aspects make it essential to work with a manufacturing partner who understands what’s at stake for your brand.
Quality is at the heart of what we do. So when we take a look at your design, we’re not just evaluating it for cost and speed, we’re evaluating how we can help you make a better product.
We focus on what matters most for your device: ensuring it's rigorously tested and reliably manufactured at scale, so you can deliver a product that makes a meaningful impact.
Certified to Build Medical-Grade Products
ISO 13485:2016
ISO 9001:2015
FDA Registered
ISO 13485: What It Means for You
As an ISO 13485 certified contract manufacturer, we operate within a globally recognized quality management system specifically designed for medical devices. But the real question is: What does that mean for you, your product, and your business? Here’s what it ensures:
Confidence in product and process quality
You can trust that your product will be built consistently and correctly because the certification requires strict controls around processes, documentation, and staff training. It’s about building a quality product in a repeatable and auditable way.
Reduced risk and greater supply chain reliability
From ensuring consistency on the production line to selecting the right vendors and material suppliers, ISO 13485 emphasizes risk mitigation at every step. It also supports traceability which is critical for post-market reporting, recalls, or regulatory review. Learn more about the importance of traceability.
Company-wide commitment to quality and continuous improvement
This certification is a mindset that runs through our entire organization. We are continuously improving our personnel training, processes, and factory environments.
Medical Device Contract Manufacturing Services
Even the best product idea can hit roadblocks if it's not designed with manufacturing in mind. That’s why we support your team with hands-on engineering services early in the process helping save time and reduce headaches later.
Design for Manufacturing (DFM)
We work closely with your engineers to identify risks, simplify builds, and make smart trade-offs all while protecting product integrity.
Test Fixture Design
We design custom test fixtures to ensure every unit functions as expected, even at volume. That means fewer failures and stronger customer confidence.
Medical PCB Assembly
Our facilities are equipped for high-quality printed circuit board assembly, including surface-mount technology (SMT) and rigorous testing and inspection that meets the needs of Class I & Class II medical devices.
Medical Device Design and Manufacturing
When you’re ready to scale, we are here for you. Our contract manufacturing services support you from first build through mass production:
- Component sourcing and supply chain management
- Quality control and inspection at every stage
- Regulatory compliance and documentation support
- Final assembly and packaging
Manufacturing in Mexico and China: What Works Best for You?
Your needs may change over time and your supply chain should adapt with you. That’s why SEACOMP operates factories in both Mexico and China, with shared systems and standards across both.
Medical Device Manufacturing in Mexico
Ideal for North American companies looking to shorten lead times, simplify logistics, and reduce tariffs. Great for high-volume runs and fast regional fulfillment.
Medical Device Manufacturing in China
Best for high-volume production with greater cost sensitivity. Leverages strong local component sourcing for global scale.
We’ll help you choose the right region, or transition between them, based on what works best for your business and product.
Learn more about the advantages to manufacturing in Mexico or China →
Nearshoring Success for FDA-registered Portable Dynamometer & Inclinometer
ActivBody sought a reliable manufacturing partner closer to home to help scale their ActivForce rehabilitation device. By moving production to Mexico with SEACOMP, they gained faster communication, improved supply chain stability, and shorter lead times.
Read the Case StudyWhy Work with SEACOMP?
We support product leaders who want to protect their brand and scale smart in their medical device production. Here's how we help:
- Reliable and Flexible Supply Chain
U.S. support with factory locations in Mexico and China lets you build where it makes the most sense for your medical technology.
- Quality That Protects Your Brand
Our certified processes and quality systems are built to meet medical standards and customer expectations.
- Speed to Market
With our in-house engineering team and local support to your time zone, we iterate the DFM process quickly helping keep your product development timeline on track.
- A Partner That Grows With You
Our equipment and dual factories allow us to meet your production volumes now and in the future.
Medical Products We’ve Helped Launch
Motorized Therapy Device
This therapy device uses both cold and compression to promote healing in patients recovering from shoulder or knee surgery. Plus, its simple and compact system can be easily transported from medical treatment facilities to a patient's home, extending treatment benefits.
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
This Class I electric toothbrush motivates users to develop great brushing practices due to its 4 sonic-powered customizable modes, long-lasting battery, and gum health setting. Connecting to the app means taking dental health to the next level with customizable settings and tracked habits.
Our Support
- Custom Charging Stand with 5W Wall Adapter
- Test Fixture Development
- Mechanical and Electrical DFM
- Tooling Design
- IPX7 Test and Validation Plan
Wearable CGM Sensor
With just a quick look at a smartphone or smartwatch, people managing diabetes can monitor their glucose levels and receive warnings when needed. This discreet and wearable Class II smart sensor provides real time readings without the need for scanning or finger sticks.
Our Support
- Medical Wall Adapter
- Custom Braided USB Charging Cable
- IEC 60601 Medical Compliance
- Global Certifications
- Product System Aesthetics
Medically Certified Power Supplies
Power Adapters for Your Medical Device
Need a power solution for your medtech? We offer medically certified power supplies through our HDP Power brand. These off-the-shelf units meet IEC 60601-1 standards, saving you time and helping you stay compliant.
View Medical-Grade Power Supply