Conducting the biological evaluation of ePatch for DELTA

The technology company DELTA recently developed a new product known as ePatch, designed to measure surface bio-signals through human skin. DELTA approached us to conduct a biological safety profile on the entire ePatch product group. Our performance of the safety profile helped the company register one of its ePatch devices successfully.

The device includes a sensor and an electrode. The ‘one-time use’ electrode stays in contact with the skin for up to seven days. Combined with the reusable sensor, the device can be used for much longer. By changing the electrode regularly, patients can use the ePatch system for more than a month.

We performed the biological safety profile on the ePatch product group, based on a worst case assumption of materials used in the medical device. Using characteristics and technical information provided by DELTA, we conducted a biological evaluation of the ePatch sensor and electrode. Since rules vary from country to country, we ensured that the evaluation was in accordance with national legislation and international regulations.

Our biological evaluation provided the base for DELTA’s registration process of one of the ePatch devices. DELTA can also use the evaluation for CE marking of the ePatch. The marking indicates that a product is compliant with European Union regulation. This would allow for free movement of the ePatch within the European Economic Area.