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 and ISO 13485.

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 ISO 9001:2015

• Quality management systems for medical devices:

pdf-icon EN ISO 13485:2016

• Medical device directive - EC Certificate:

pdf-icon EC Certifikat

 

Images:

01_ISO 13485-2016 Iskra Medical EN.jpg02_ISO 9001-2015 Iskra Medical EN.jpgEC Certificate 2019-MDD-QS-022 - Iskra Medical devices EN 01.jpgEC Certificate 2019-MDD-QS-022 - Iskra Medical devices EN 02.jpgEC Certificate 2019-MDD-QS-022 - Iskra Medical devices EN 03.jpg

 

QUALTY POLICY

Iskra Medical d.o.o. is committed to manufacturing and selling medical devices that meet demands of customers and satisfy their needs. Our products comply with international standards and regulations for medical devices. These products enable our company to have good business performance. Our company constantly strives to protect the environment. The top management of the company is committed to continuously improve the quality management system and is committed to ensure that applicable requirements set by the quality management system are meet. These principles are the basis for the company’s quality policy outlined in the following list:

• Company endeavours to meet and exceed quality standards in the field of medical devices set by leading manufacturers of medical devices worldwide.
• Sale and resale of environmentally friendly products. To this end all intermediate products are analysed, control development, selection of the most appropriate technologies and careful attention to manufacturing process.
• Company always seeks to comply with the demands of the customers regarding the quality of its products. All company’s products meet or exceed quality levels set by standards. Company places utmost importance on the demands of the customers and is company’s main competitive advantage. Company sells environmentally friendly products that are the end result of precise manufacture, quality control and quick response to any deviations in the process.
• Company’s sales process is adjusted to the demands of the market, laws and standards. Our system of control enables us to catch any deviations in time to correct them before they could cause any harm to the user or the environment.
• The company achieves competitive advantage through prompt responses to needs and wishes of the customer, no matter what the size of the business. Our speciality is also meeting unique needs of our customers.
• All participants in the business process must be acquainted with all the demands of the customers. They also need to possess appropriate knowledge and experiences to perform their work and to protect the environment.
• The company regularly checks expenses related to quality control and performs actions for their control.
• Company invests a lot of efforts in to training in the fields of medicine, quality control, functional knowledge and legal issues.

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