Medical devices by Electropulse comply with EU norms
The Russian developer and producer of medical devices Electropulse has successfully undergone QMS conformity assessment as per ISO 9001:2000 and ISO 13485:2003 as well as verification of its products’ conformity to the EC Directive 93/42/ЕЕС. The company obtained relevant certificates.
“In order to be able to deliver products outside Russia one needs to comply to international regulations, and to export to EU countries manufacturers have to conform to European Directives requirements,” – says the Quality Manager with Electropulse Ltd. Julia Tyuftyakova.
The key motivation to launch and certify the QMS in accordance with ISO 9001 and ISO 13485 аs well as to certify medical devices in accordance with Directive 93/42/EEC has been the strategic decision of Electropulse management to enter the European market. Besides, the certificates will enable Electropulse to improve its image in the region and in the industry, to get advantages over competitors while participating in tenders, to implement projects jointly with international organisations.
As a result of the carried activities electrosurgical and diagnostic complexes by Electropulse got the right to be marked by СЕ mark as a proof of their conformity to 93/42/ЕЕС Directive requirements. Those products have been among the first in Russia to bear CE mark in such a high class of potential risk as IIb.
QMS certification and verification of products’ conformity to European regulations have been carried out by SGS – the global leader in inspection, verification, testing and certification services, active in the Russian market for already 25 years.