Strict ISO 13485:2016 standards and 25+ years of hardware experience you can rely on
Standardized and Automated Processes
Automated production environment designed for complex products with built-in fail-safes for product consistency
Multiple Quality Control Checkpoints
Gated route environment and custom testing is one of many ways we ensure products are built error-free
Traceable Device History
Batch-level component tracking provides visibility and traceability throughout a product’s lifecycle
Our robust and secure quality management system ensures compliance with industry standards, material directives and regulatory requirements.
Earning ISO 13485:2016 and ISO 9001:2015 demonstrates our commitment to the highest quality standards for medical product manufacturing. Using only RoHS and REACH certified products demonstrates our commitment to your ability to acquire a Certificate of Conformity.
Standardized and Automated Processes
Superior production and testing standards for hardware and software consistency
- The industry's most technologically advanced manufacturing floor specifically designed for complex builds
- Risk assessment standards integrated into the product design phase to ensure consistent manufacturability
- Visual build documents developed during prototyping contribute to 99.6% workmanship accuracy
- Strict version control protocols for image management and hardware and software validation
Multiple quality control checkpoints
Only MBX has the confidence to give customers full visibility into orders in progress by work center
- Gated routes assure each unit's quality is checked before progressing to the next work center
- Multiple visual inspections in production and warehouse covering every product touchpoint
- Environmental controls implemented across our manufacturing facility protect components, including ESD flooring and temperature and humidity controls
Traceable device history
Consolidated device records in Hatch set the stage for smooth product auditing
- Environmental controls implemented across our manufacturing facility protect components, including ESD flooring and temperature and humidity controls
- Manufacturing accountability and records demonstrating proof of compliance and conformity
- 24/7 visibility into the current status and location of the product and the activities logged for the product
- Intelligence on any failed components
More Capabilities
Value Analysis Value Engineering
We’ll seamlessly manage your product deployments while you seize new markets
Product Lifecycle Management
Platforms designed and maintained with the longevity of your products in mind
Quality Management
With your name on it, every product has to work right out of the box. We stake our reputation on safeguarding yours
Supply Chain Traceability
The faster and easier you can access your hardware program data, the smarter your operations can function
Design for Manufacturing
Take your technology to market without the challenges of making it work on hardware
Looking for the right hardware solution? We're here to help.
Get In Touch
Since you found us before we found you, we owe you one. Let us show you how we can deliver on everything we say.
