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Can I develop a medical device with biosignalsplux?

Yes, although biosignalsplux is not a medical device, it meets all the required regulatory hardware standards to allow customers to develop medical devices using biosignalsplux products.

biosignalsplux devices have been tested for safety and reliability according to medical grade hardware standards, enabling them to be integrated into medical device solutions.

You can either develop your own software solution using the PLUX APIs or contact our R&D Engineering Team for a custom hardware development project.

In addition, while it lies within the customers’ responsibilities to certify the final product (including the biosignalsplux products), we can support the process by providing all the necessary documentation which is in accordance with our ISO 13485 certified Quality Management System (QMS) for medical device development.

Updated on 28 de March de 2023

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