ISO 13485 is a voluntary standard that certifies, with regards to CE marking, medical device management systems to ensure regulatory compliance at all stages of their life cycle: design, production, installation, technical assistance and sales.
The service is applicable to active, non-active, implantable, non-implantable and in vitro diagnostic medical devices.
Certification according to this standard offers added value to the system elements required for CE marking, for the marketing of medical devices within the European Union.
In particular, the standard certifies the drafting of the product technical dossier, the analysis and management of the device safety, the traceability of the product and its components.
The ISO 13485 standard can be integrated with ISO 9001 and provides the basis for the management systems laid down in the Directives 93/42/EEC (medical devices), 90/385/EEC (active implantable medical devices), and 98/79/EEC (in vitro diagnostic medical devices).
RINA is accredited by ACCREDIA and ANAB for ISO 9001:2008 in the sector 38 - Health and Social Services. Our team issues numerous certifications, both in Italy and abroad, to hospital units, clinics and nursing homes, laboratories, rehabilitation services and social care.