Achieve ISO 13485 certification and strengthen quality, safety and compliance for medical devices
In the medical device sector, regulatory compliance is essential for operating and competing in the market. Demonstrating process quality and effective control is now fundamental to gaining market access and maintaining a long-term presence.
Regulation (EU) 2017/745 (MDR – Medical Device Regulation) has raised requirements for safety, traceability and risk management across the entire supply chain: from manufacturers and component producers to subcontractors, service centres and distributors. ISO 13485 certification is the internationally recognised benchmark for quality management systems in the medical device sector. It supports organisations in demonstrating reliability, regulatory compliance and process control, while facilitating access to national and international markets.
The ISO 13485 certification service is intended for all organisations involved in the medical device supply chain, including manufacturing, assembly, technical services and servicing activities. Certification is carried out through third-party audits conducted by RINA according to a structured programme that includes:
Upon request, a voluntary pre-audit can be carried out to identify any gaps against the standard’s requirements and prepare effectively for the certification audit.
The service is governed by a three-year contract issued on the basis of the information provided in the Information Questionnaire, which is required both at the initial stage and at each renewal.
RINA provides qualified auditors who are continuously updated on the MDR (Medical Device Regulation) and sector-specific regulations. We support organisations with a structured approach and a reliable certification process recognised nationally and internationally.
Yes. ISO 13485 is based on ISO 9001 principles but introduces requirements specific to medical devices, in line with the European MDR regulatory framework.
No. Certification is applicable only to organisations performing activities related to medical devices throughout their life cycle.
