Equipment for Neuropathy analysis

Process

When ECT got involved in the project, the product was fully functional and passed clinical tests. The product did not meet regulatory demands in relation to Medical Class 2a, and ECT helped define the problem and redesigned the hardware.

Challenge

The problem was related to security to the patient in case of components getting defective. The challenge was to identify all the cases of the Risk Analysis, and to implement a hardware solution that could be accepted by the Notified Body – and at the same time did not affect the primary function of the device or other regulatory matters.

Challenge

The problem was related to security to the patient in case of components getting defective. The challenge was to identify all the cases of the Risk Analysis, and to implement a hardware solution that could be accepted by the Notified Body – and at the same time did not affect the primary function of the device or other regulatory matters.

Solution

ECT went into discussion with the Notified Body and identified the problem. We also discussed other parts of the Risk Analysis to understand if the identified the solution would solve all problems. A new hardware design was developed, tested and debugged before releasing documentation to the client, to the Notified Body and to the factory for mass production.

Before ECT was involved the product was fully functional, but without Regulatory Approval, it cannot be commercialized. Even though ECT was just a small part of the final phase of the project, this part was very important for the product.

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