When manufacturing Class I and Class II medical devices, you need a partner who has the correct experience and certifications. SEACOMP supports innovators in medtech by getting their product to market, collaborating on everything from design to assembly.
ISO 13485 Certified Manufacturing
We ensure quality, reliability, and access to international markets with our robust certifications and compliance standards. ISO 13485 is key to enhancing your global growth and promising product integrity. Our certified production facilities maintain this as a top priority.
Design & Engineering Services for Medical Devices
Finding a manufacturing partner that provides complete end-to-end product design and manufacturing services can be a huge benefit when you’re working to get a new medical or personal health device to market. SEACOMP has extensive experience in successfully launching medical devices, and we can help avoid pre-production and production pitfalls. While you focus on the big picture, we handle the details from start to finish.
- New Product Introduction
- Certification Management
- BOM Analysis
- Turnkey and Complete Box Builds
- Design for Manufacturability (DFM)
- Design for Assembly (DFA)
- Design for Supply Chain (Component Validation)
Electrical Hardware Design
- Schematic Design
- IC Component Selection
- Printed Circuit Board Design, including: PCB Layout, PCB Testing
- Design Validation Testing (DVT)
- Engineering Validation Testing (EVT)
Embedded Software Design
- Firmware Development
- Device Drivers
- Microcontrollers and Microprocessors (Bare Metal, RTOS, OS)
- Embedded Graphical User Interface Design
- Wireless Design and Development for Connected IoT
- 3D Printing for Industrial Design
- Soft Molds
Test Fixture Design
- Develop and Design Test Fixture
- In-Circuit Testing and Programming
- Functional Testing
- Fixture Validation
- End-of-Line Fixture
Medical Device Manufacturing Capabilities
SEACOMP has an in-house team of hardware, firmware, mechanical, and electrical engineering experts that will work with you and your team to meet your product vision. Our cross-functional team takes pride in finding the best way to bring your product to life and make sure it’s ready to scale. Our in-house manufacturing capabilities include:
- Plastic Injection Molding
- Surface Mount (SMT Assembly)
- Through Hole Mounting
- PCB Assembly (PCBA)
- Ultrasonic Welding
- Program and Test Equipment
- Burn-in Equipment
- Pad Printing and Laser Etching
Medical Devices We’ve Brought to Market
SEACOMP’s proven NPI (new product introduction) process has helped us bring numerous new medical devices to market with our partners. Below are just a few examples of some of the great products we’ve helped launch.
MOTORIZED COLD THERAPY AND COMPRESSION DEVICE
Designed to optimize post-surgery patient recovery by reducing pain from shoulder and knee procedures. Plus, its simple and compact system can be easily transported from medical treatment facilities to a patient's home, extending treatment benefits.
- 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 4 sonic-powered customizable modes, long-lasting battery, and gum health setting, this Class I electric toothbrush empowers users to develop great brushing practices. Connecting to the app means taking dental health to the next level with customizable settings and tracked habits.
- 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
With just a quick look at a smartphone or smartwatch, diabetics 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 fingersticks.
- Medical Wall Adapter
- Custom Braided USB Charging Cable
- IEC 60601 Medical Compliance
- Global Certifications
- Product System Aesthetics
Power Supplies for Medical Devices
For electronic medical devices, the correct power supply is critical. SEACOMP offers the IEC 60601-compliant Medite Power Adapter to power medical devices. Medite is an ideal, cost-effective power solution for a certified medical adapter and can be customized to meet the needs of your device.
Partnerships Built to Last
We believe that happy people make better products, and how we do business reflects this. We’ve built strong partnerships with a number of medical device companies who trust us — both to protect their IP and to help them scale their products into the future.