Managing the test standards and processes for compliance
Design Controls
Identifying your product design needs and maintaining design history documents to ensure they’re built consistently
Test Management
Whether it’s testing for regulatory compliance or for global exportation, we’ll manage the entire testing process for you
Design and Device History Traceability
Maintain easy access to the historical documentation that’s required for manufacturing and tracking devices
Keeping your device compliant throughout the design and development process
Considering the complexities of medical device design and manufacturing, it’s important to work with a hardware partner with proven processes to ensure usability, safety, and regulatory compliance.
Design Controls
Controls to help you bring safer medical devices to market faster
- System design with the primary intent of medical device compliance
- Engineering evaluation to verify the design meets applicable regulations and performance parameters
- Iterative design review and testing protocols and reports in Hatch
- Standards established to streamline the manufacturing validation process
Test Management
In-house compliance expertise to manage the entire process
- Strong test strategy to ensure adequate testing while also controlling costs and avoiding delays
- Risk management standards maintained across all phases of design engineering
- Dedicated in-house resources to manage working with independent testing labs
Design and Device History Traceability
Documents are easily located in Hatch, saving valuable time and resources
- Seamless traceability of every hardware change throughout the product design process and beyond
- Documentation of device master record used in the build process
- Each production unit serialized and searchable by date of manufacture, labeling, and any other unique identifier
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.
