Equipment for Neuropathy analysis
Medical electronic product Class 2a
Process
The Equipment for Neuropathy analysis was fully functional, and had passed clinical tests. However, the product did not meet regulatory demands in relation to Medical Class 2a. Therefore, ECT was involved.
ECT was in charge of:
– Defining the problem
– Re-design of hardware.
Challenge
Equipment for Neuropathy analysis is a medical device. Therefore, the regulatory approvals are more difficult to meet. Especially, Patient Safety is very important. In this case, the problem was related to security in case of defective components. Therefore, the challenge was to identify all the cases of the Risk Analysis, and to implement a hardware solution. At the same time, without affecting the primary function of the device, or other regulatory matters.
Challenge
Equipment for Neuropathy analysis is a medical device. Therefore, the regulatory approvals are more difficult to meet. Especially, Patient Safety is very important. In this case, the problem was related to security in case of defective components. Therefore, the challenge was to identify all the cases of the Risk Analysis, and to implement a hardware solution. At the same time, without affecting the primary function of the device, or other regulatory matters.
Solution
In order to solve the problem, ECT went into discussion with the Notified Body. Thereby, the problem was identified. Also, we discussed other parts of the Risk Analysis. In this case, to understand if it would solve all problems. As a result, ECT developed new hardware. It was tested and debugged before it was released to the client, Notified Body and the factory.
Before ECT was involved, the product was fully functional, but without Regulatory Approval. Therefore, it could not be commercialized. Even though ECT was just a small part of the project, it was very important for the product.
