Medical devices supply

What the service includes

Medical machinery
Blood pressure monitor

The Standard ISO 13485:2004 is relative to the medical devices sector, and specifies the requirements for a quality management system for use by the companies responsible for the design and manufacture of devices as well as by the companies that design and deliver services related to them.

UNI EN ISO 13485:2004 is structured according to the scheme of standard ISO 9001 to facilitate the harmonisation of regulatory requirements for medical devices for the quality management systems.

The standard is applicable to:

  • producers of devices subject to CE marking (all Ministerial Decree classes);
  • suppliers of particular processes associated with the production of the devices (sterilisation, storage, transport);
  • companies that distribute and market medical products;
  • companies that provide services related to the devices (installation, maintenance and repair, clinical engineering).

The UNI EN ISO 13485 certification allows you to receive significant benefits:

  • for manufacturers of Medical Devices subject to conformity assessment procedures with intervention of a Notified Body in accordance with Annexes II, V, and VI, the EN ISO 13485:2003 certification provides the presumption of conformity of the quality system adopted;
  • for manufacturers of Class I (self-certification) Medical Devices, the 13485 certification enables direct and independent verification on prepared activities to meet the requirements of Directive 47/2007 and preliminary to any market surveillance activities carried out by the Italian Ministry of Health;
  • for companies that distribute or market medical products and for companies that provide services related to the devices, the 13485 certification allows participation in tenders published by the Public Administration.

The ANCCP Certification Agency certifies companies in accordance with UNI EN ISO 13485.

Share by: