End-to-end Product Development
End-to-end Product Development
End-to-end Product Development
Services at ND Global strictly adhere to ISO 13485 and FDA-compliant procedures, complemented by our innovative methodology.
We deliver customized, reliable solutions tailored to your target market and users. Our approach considers critical factors such as technology, clinical, commercial, and legal, ensuring project success. We emphasize precise problem definition and risk mitigation early on, resulting in a thoroughly tested final product that perfectly aligns with customer needs and is ready for distribution. Trust us to narrow down the medical device design options, delivering world-class design experiences and exceptional outcomes.
How can we help?
Feasibility
ND GLOBAL develops a rough idea of what your device will look like, its intended use, and how users will use it. Through market research, we will ensure your product aligns with user needs and define the regulatory pathway.
Design & Implementation
As we create a mechanical, electrical, software, and integration-based clinically viable, preproduction device, ND GLOBAL converts the requirements into a documented structure.
Planning
ND GLOBAL creates a design and development plan, standards to be followed, risk management, and usability
Testing
Although we test medical device designs at every stage of their development to ensure they are headed in the right direction, we only perform formal testing once the production equivalent has been created.
Requirements
ND GLOBAL defines the primary function of devices and writes the user, product, software, and hardware requirements.
Regulatory Submission
To ensure that all necessary regulatory controls for safety and effectiveness are met, we submit your device to the relevant regulatory authority.
