Vivanotec Pro Negative Pressure Wound Therapy

During the design transfer, seleon, together with its partner network, had the opportunity to provide the customer with additional support in the manufacturability of the product using various approaches. Suitable technology partners were selected, different manufacturing processes were tested, suitable materials were identified and ultimately, together with the customer, the approval of a Class IIa medical device was obtained.

There are now three different versions of the VivanoTec Pro, which are produced by seleon.The product is used in numerous countries and on three continents. Since the start of the pilot series, seleon has produced, delivered and serviced several thousand devices.

A special feature of the production of the negative pressure therapy unit is that it can be operated with a lithium-ion battery and is therefore mobile. seleon must ensure that only devices with fully charged batteries are dispatched to the customer and thus charged shortly before delivery.

seleon was responsible for the entire materials management cycle (procurement of raw materials, quality controls, supplier management, delivery date monitoring), the assembly of the devices in accordance with EN 13485, the testing of the devices including electrical safety testing, functional testing and, depending on the variant, a high-voltage test. The appliances are packaged, fitted with country-specific accessories and then shipped from Dessau to numerous countries and three continents on a decentralised basis. The same applies to the recurring service of the vacuum therapy units.