Quality
Peace of mind for doctors and patients alike
Our Commitment to Quality
ISO 13485 and
MDSAP Certified
Why is this important?
In our unrelenting efforts to ensure patient safety, achieving ISO 13485 and MDSAP (Medical Device Single Audit Program) certification became a necessary milestone. Our quality system has undergone a rigorous certification process to establish confidence in the quality, safety, and effectiveness of the medical devices we manufacture. Compliance to ISO 13485 and MDSAP also opens us up to international markets, streamlines our processes, and ultimately allows Neuronoff to run a more profitable and risk-averse operation.
Quality by Design
Patient peace of mind is central to all we do. Our commitment to quality starts at the very inception of the medical technologies we develop, and our efficient structure allows for all departments to operate seamlessly throughout the development process, ensuring safety and compliance. We have adopted ISO 14971 Risk Management Process throughout all phases of the device life cycle.
Safety by Design
We mitigate risk of neuromodulation treatments by truly focusing on how patients want to be treated. Most neuromodulation devices have batteries and complicated firmware to control the devices, while we minimize risk by not using batteries. Additionally, our needle-based delivery platforms leave no scars and can be removed in a minimally invasive manner.
Reliability by Design
To further reduce risk, we strive for minimal component systems with a concise manufacturing process and apply rigorous standards ensures reproducibility. We use data driven techniques to ensure that our designs are effective and our manufacturing processes are reliable. We believe in simple, clean, elegant, solutions that reduce risk and maximize effectiveness.
Quality Policy
At Neuronoff we are accountable for ensuring quality of products and services while meeting the needs of our customers and operating under a Quality Management System in accordance with global regulations and standards that supports continuous product and process improvement.
Our Guiding Values
Integrity
We stand behind all of our products and procedures
Accountability
When we commit to goals we follow through
Reliability
Designed to help patients and designed to last
Simplicity
With simplicity comes predictability
Humility
We encourage patients to seek out the best possible treatment options, whether that is with or without our technology (once approved)
Proudly Manufactured in Cleveland, Ohio
We utilize a concise supply chain of carefully curated and qualified components, sourced from only approved suppliers. Our devices are manufactured in the medical hub of Cleveland, Ohio, surrounded by the Cleveland Clinic, Case Western Reserve University, Great Lakes NeuroTechnologies, Integer and many more. Our experienced team is trained and certified in the USA.