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Service Description

Our consulting services ensure that supplier management processes comply with the requirements of ISO 13485 and the European Medical Device Regulation (MDR), ensuring the quality and safety of medical devices. We focus on: - Drafting technical/quality agreements with suppliers aligned with ISO 13485 standards and MDR regulatory requirements, establishing clear accountability and compliance criteria. - Auditing suppliers to verify their compliance with ISO 13485, ensuring the correct implementation of documented processes, product traceability, and risk management. - Implementing a risk-based monitoring system, compliant with ISO 13485 and MDR regulations, to ensure continuous oversight and mitigation of supply chain risks.