Event:

01 Apr 2017 KONGRES KOZMETIKOV, Bernardin, Portorož
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Event:

06 Apr 2017 AESTHETIC & ANTI-AGING MEDICINE WORLD CONGRESS 2017 AMWC, Monaco, France (Congress)
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Event:

13 Nov 2017 MEDICA 2017, Düsseldorf, Germany (Fair)
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Iskra MEDICAL is a leading manufacturer of devices for physiotherapy, rehabilitation, and estetic medicine.

Currently, our production assortment includes the electrotherapy, ultrasound, vacuum, laser, pressure, magneto, intense pulse light, and radio frequency equipment, but we constatnly continue to broaden our family of quality medical in cosmetic products.
The starting point in development of a new product is to study the intended purpose of the device, and consider the needs from practitioner’s point of view. The user-friendly operation, efficacy and safety are the main criteria in development.

 

The company has a Quality Management System certificate in accordance with ISO 9001:2008 and ISO 13485:2012.

The devices are compliant with EU Medical Device Directive MDD 93/42/EEC and have received an EC certificate through Notified Body 2265 (3EC International).

 

 

Iskra Medical Certificates

The quality system was conceived in accordance with the requirements of the international standards of quality ISO 13485, ISO 9001 and the Medical Device Derective of the European council no. 93/42/EEC and other directives depending of the nature of products.

 

Download certificates (pdf):

• Quality management systems:

pdf-icon EN ISO 9001:2008

• Quality management systems for medical devices:

pdf-icon EN ISO 13485:2012

• Medical device directive - EC Certificate:

pdf-icon MDD EC Certifikat

 

Images:

Iskra-Medical-EC_Certificate-005-A.jpgIskra-Medical-EC_Certificate-011-A.jpgIskra-Medical-EC_Certificate-015.jpgIskra_Medical_ISO9001.jpgIskra_Medical_ISO13485.jpg

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