Certification and awards

77 Elektronika Kft. is committed to develop, produce and supply high-quality products and services. Our essential objective is to meet the requirements of our customers and distributors. 77 Elektronika’s quality management system has been certified by TÜV Rheinland InterCert Kft. according to Standard ISO 9001 and ISO 13485, since 1996 and 2000, respectively. We were the first company in Hungary to earn ISO 13485 certification. Later on the quality management system of 77 Elektronika has been completed with Taiwanese and CMDCAS (MDR) regulations, as well. Our certificates are regularly renewed in compliance with the most recent standards.


ISO 9001 is the international standard for consistent performance to the satisfaction of customers. Standard ISO 13485 is mostly based on the structure of ISO 9001, yet also includes certain specific requirements relating to medical devices. It sets forth the requirements of a comprehensive quality management system for the design and development, production, installation, servicing and sales of medical devices. The ISO 13485 certificate demonstrates that our quality management system has been assessed and found compliant with the relevant regulatory requirements and customer needs.


The application of Directive 98/79/EC on in vitro diagnostic medical devices ensures that all of our products are safe and effective in conformance to clearly outlined regulations regarding development, manufacturing, marketing and servicing. To demonstrate our compliance with the IVD Directive, CE marking is affixed to all of our products. According to the IVD Directive, the manufacturer is required to issue a declaration of conformity for each product. In the case of our urine analyzers, further certification is not necessary for product qualification while our blood glucose meter systems classified under Annex II list B are certified by a notified body, as well.


In addition to assuring the high quality of our products, the company is also concerned with its impact on the environment. For this reason, in 2003 our environmental management system has been assessed and certified under ISO 14001.



Besides official certification 77 Elektronika has already won numerous quality awards announced by different organizations:

  1. Special Prize of the Hungarian Design Award for LabUReader (Vision 2000) urine analyzer in 1999. (Announced by the Hungarian Design Council)

  2. Innovation Grand Prize for Dcont Personal blood glucose meter in 2000. (Announced by the Hungarian Association for Innovation)

  3. Industrial Innovation Award of the Ministry of Economy and Transport for (LabUMat & UriSed) "automatic urine laboratory system" in 2007. (Announced by the Hungarian Association for Innovation)

  4. Hungarian Quality Product Award and Special Innovation Prize for (LabUMat & UriSed) "automatic urine analyser system" in 2010. (Announced by the Hungarian Authority for Consumer Protection, TÜV SÜD KERMI KFT, ITD HUNGARY, MEHIB PTE LTD, EXIMBANK HUNGARY PLC, TERC LIMITED and INDUSTORG-VÉDJEGYIRODA KFT.)

 

ISO 9001 & 14001
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ISO 13485
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