Pelvic Floor Rehabilitation Device

Ljubljana, Slovenia

Iskra MEDICAL is a leading manufacturer of devices for physiotherapy, rehabilitation and aesthetic medicine. Currently, our production range includes electrotherapy, ultrasound, vacuum, laser, pressure, magneto, light pulse and radio frequency devices, but we are constantly expanding our family of quality medical and cosmetic products. The starting point for the development of a new product is to study the intended use of the device and consider the needs of practitioners. User-friendly operation, effectiveness and safety are the main criteria during development The company has a certificate for a quality management system in accordance with ISO 9001 and ISO 13485. The devices comply with the EU Medical Device Directive MDD 93/42/EEC and have received an EC certificate from the notified body 2265 (3EC International) Iskra Medical certificates The quality system has been developed in accordance with the requirements of the international quality standards ISO 13485, ISO 9001 and the European Council Directive on Medical Devices No. 93/42/EEC and other directives, depending on the type of products.