WE CONTINUE TO BE CHOSEN BY PROFFESSIONALS
+381113345626
General Anouncements

english...

ISO 13485 Medical Device Quality Management System

ISO 13485 CRETIFICATION

ISO 13485 standard has been developed to set out the requirements and special conditions fort he manufacture of medical devices The base standard which it comes is ISO9001 quality management systemstandard which needs to be read in conjunction with ISO 13485. ISO 13485 standard is a system that manufactures can use when seeking CE marking. The standard extends on ISO 9001 with additional specified requirements at the design stage in particular and some other areas related to medical devices production.

ISO 13485 is a standard that describes specific conditions for providing quality systems for companies producing medical devices, cover trade production areas and related services including project management production, installation and supply stages.   

Benefits of ISO 13485 Certification

  • Providing a competitive advantage compared to other companies who are not certified.
  • Increasing the quality consciouness of the company staff
  • Adoptig a process aproach to manufacturing processes
  • Developing documentation that provides a platform for standardisation of company activities.
  • Increasing respectability of the establishment in the eyes of the market.
  • Providing global assurances of conformance to quality rules for medical devices.
  • Increasing the efficiency and effectiveness of design.
  • Providing advantage in exporting, especially to the Europan Union countries.
  • Increasing the trust that can be had in devices produced.
  • Protecting human health thanks to the increasing production quality of devices.
  • Faciliating compliance to various laws and regulations related to medical devices manufacture
UDEM BALKANS D.O.O.
2019 © | All Rights Reserved
Address: 27. Marta 25a/4 Palilula Belgrade
Tel: +381113342284 Fax: +381113345626 E-Mail: info@udembalkans.com