ISO 13485 is a voluntary standard which, for the purpose of obtaining CE-marking, certifies the management systems of medical devices in order to ensure they comply with the standard throughout their life cycle: design, production, installation, servicing and sales. In particular, the standard certifies the definition of the technical product brief, the safety analysis and management of the device, and traceability of the product and its components.
ISO 13485 can be integrated with ISO 9001 and lies at the basis of the management systems indicated by community directives 93/42/EEC (Medical devices), 90/385/EEC (Active implantable medical devices) and 98/79/EEC (In vitro diagnostic medical devices).
Conformity with Community standards on Management systems, applied to the specific medical device sector
- added value for the system elements required for CE-marking purposes
- transparency of the information provided to operators and patients
- improvement in the health and well-being of patients
- monitoring of health spending, an important cost item of which are medical devices
- marketing of medical devices within the European Union.
WHY RINA SERVICES?
RINA SERVICES has developed its professionalism in this sector thanks to the elevated competence of its staff, matured through constant investments in training and in the selection of specific resources.
Our extensive experience has allowed us to obtain:
- dual ACCREDIA and ANAB accreditation for the ISO 9001:2008 scheme in sector 38 - Health and Social Services
- numerous certifications, both in Italy and abroad, at hospitals, clinics and nursing homes, laboratories, rehabilitation facilities and social services
- qualification of audit teams.
The certification procedure involves:
- compilation and dispatch of the questionnaire
- definition of the offer and stipulation of the contract
- optional pre-audit
- initial certification audit and documents review
- issue of certificate
- annual surveillance audits
- recertification audits (every 36 months).
What types of device does certification apply to?
It applies to active, inactive, implantable, non-implantable and in-vitro diagnostic medical devices.