Risk Management - ISO 14971

Market Access for your medical device and in vitro diagnostic 

Risk Management

Need support getting your risk management file ISO 14971 compliant?

Medical device firms must implement a risk management process that adheres to ISO 14971, which is a recognized standard for risk management by various regulatory bodies, including those in the US, Europe, Canada, Australia, and others. Adopting ISO 14971 enhances the ability of an organization to mitigate uncertainty and guarantee the safety and efficacy of their devices.

ISO 14971 provides a structured approach for managing the risks associated with medical devices and in vitro diagnostics. For optimal results, it should be integrated into your company's quality management system (QMS) as mandated by ISO 13485. Our team of regulatory affairs and quality assurance consultants, with their deep understanding of the process and commitment to patient safety, can assist you in meeting the requirements of ISO 14971:2019 in a cost-effective and efficient manner, globally.

Our Risk Management Services

Planning - Define the scope of risk management activities and integration with your QMS.
Documentation - Identify gaps and opportunities for improvement.
Risk Analysis - Assist manufacturers in prioritizing and addressing risk management activities for thorough analysis of risks related to their devices.
Post Market Surveillance (PMS) - Completing risk management and ensuring that the Post Market Surveillance (PMS) input integrates into risk management.

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