WISE Srl is a Milan- and Berlin-based medical device company developing a genuinely new generation of implantable leads for Neuromodulation and Neuromonitoring.
Currently, WISE is clinically validating its WCS electrode for intraoperative neurophysiological monitoring and completing the development of the SCS Expert lead, the first multi-column SCS paddle lead that can be implanted percutaneously by a Pain Therapist.
WISE’s electrodes are highly ergonomic, conformable, soft and thin, thus allowing great adhesion, minimal invasiveness and excellent adaptability on neural tissues and allowing to 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.
WISE’s disruptively innovative technology allows to produce electrodes that are strongly attached to the polymer and are stretchable, flexible, biocompatible [medical grade] and allow a very effective stimulation. Furthermore, SCBI allows to embed electronic circuits in foils as thin as a few microns without damaging the foil itself.
Thanks to its technology, WISE will revolutionize the way stretchable electronics is produced, with a wide range of applications in numerous fields, such as Med-tech, Stretchable electronics, Wearable electronics, Optics, Aerospace, and beyond.
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.