WISE Srl is a Milan- and Berlin-based biomedical company developing a genuinely new generation of implantable leads for Neuromodulation and Neuromonitoring .
WISE’s electrodes are highly biocompatible, foldable, stretchable and minimally invasive compared to existing products and will overcome the major limitations of today’s technology. They will allow to improve the treatment of patients that are already profiting from Neuromodulation, while at the same time expanding the use of Neuromodulation to fields and clinical indications in which the complex technical demands cannot be met by the current technology.
The electrodes are produced through a proprietary innovative technology: the Supersonic Cluster Beam Implantation (SCBI), which allows the metallization of stretchable polymers. SCBI consists in embedding metal nanoparticles inside a preformed polymer base in order to form a conductive metal-polymer skin on its surface. The SCBI technology has been protected by patents in Europe, USA, Israel, Canada, India, Japan and Korea. Alongside the IP, WISE holds a strong know-how on the technology and its implementation.
On 28th November 2017 WISE has adopted an Organization, Management and Control Model in compliance with the Legislative Decree no. 231 of June 8, 2001. The Model is designed to prevent the perpetration of the unlawful acts , as described in the Legislative Decree 231 and, consequently, shield the Company from administrative liability.
The Model, which was adopted following a detailed analysis of the Company’s operations to identify the activities with a risk potential, includes a series of general principles, rules of conduct, control tools, administrative procedures, information and training programmes and disciplinary systems that are designed to prevent the occurrence of the identified crimes. The Model is completed by its Annexes, which are an integral part of the Model itself, and which include the Code of Conduct of the Company.
WISE has obtained for its production site in Cologno Monzese the certification according to the standard ISO 13485:2016 (Medical devices - Quality management systems - Requirements for regulatory purposes).
The ISO 13485:2016 standard specifies the requirements for a Quality management system where an organization needs to demonstrate its ability to provide medical devices that consistently meet customer requirements and regulatory requirements applicable to medical devices.
The certification was granted by Tüv Süd on 27th October 2017, following a two-stage audit process. Tüv Süd carries out a continuous strict control in order to ensure that the quality standards of WISE’s production system are maintained over time.