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Product and Manufacturing Process Validation
At this stage, we ensure that all beta prototypes meet or surpass your expectations. We leverage advanced medical device engineering processes to validate your manufacturing claims. We also assure that your manufacturing facilities can support a quality finished product. Solid manufacturing production controls ensure efficiency and consistency in product quality.
At CUBE Medical Innovations, we utilize ISO 9001, ISO 13485 suppliers. This ensures that medical device development and quality system compliant manufacturing processes consistently produce products that meet customer requirements.
ISO 13485 Design Validation and Development
At CUBE Medical Innovations, we not only leverage automated-testing technologies to conduct electro-mechanical, failure analysis, and bio-compatibility testing on device prototypes, but we ensure that your medical device product surpasses expectations by evaluating and validating both your medical design and your manufacturing claims. Developing the product, itself, means nothing if you can’t produce these devices with assurance of quality, control, and consistency on a mass scale.
To meet your goals, we utilize ISO 9001, ISO 13485 suppliers. ISO 13485 design and development allows for a smooth transition to ISO certified manufacturers. We ensure consistency and quality with every stage from medical design to the manufacturing process.
Our iterative process integrates robust FMEA (Failure Modes and Effects Analysis) testing to isolate any malfunction potentialities. Every failure mode is investigated, and effective mitigations are developed to address flaws.
Leverage our experience to your advantage.
CUBE Medical Innovations is keenly positioned to help produce your innovative medical device using manufacturing technologies that give you a greater advantage when balancing ISO 13485 design with development in performance and price considerations.
At CUBE Medical Innovations, we enable your business to take advantage of a faster release to market using vital checkpoints to guarantee regulatory compliance from the beginning of the medical device development to the final design and manufacturing stages – all in less time.
In line with market demands, our product and manufacturing process validation produces efficiency of use and development without sacrificing functionality of your product. CUBE Medical Innovations offers you the assurance of ISO 13485 design compliance at every development stage, all while evaluating the effectiveness of scalable manufacturing potentials.
If you're ready to begin the manufacturing journey, contact us.