What is the service

L to ISO 13485: 2004 relates to the field of medical devices, and specifies requirements for a quality management system to be used by the companies responsible for the design and manufacture of devices from companies that design and deliver services related to them.

The UNI EN ISO 13485:2004 is structured according to the scheme of ISO 9001, to facilitate harmonized medical device regulatory requirements for quality management systems.

The standard is applicable to:

• device manufacturers subject to CE marking (all classes of DM);
• suppliers of special processes associated with the production of the devices (sterilization, storage, transport);
• companies that distribute and market medical products;
• companies that provide services related to devices (installation, maintenance and repair, clinical engineering).

The UNI EN ISO 13485 can receive great benefits: 

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

ANCCP Certification Agency certifies companies in compliance with the UNI EN ISO 13485.