,ISO 14971 Risk Management Consulting – Overview
Managing medical device risks can be complex; one oversight can delay approvals or compromise safety.
That’s why ISO 14971:2019 is the global gold standard, recognized by the US FDA, Health Canada, TGA, PMDA, and the EU.
At Freyr, we simplify compliance. Our experts help you identify, assess, and control risks for medical devices, SaMD, and IVDs, ensuring your systems align with the latest ISO 14971 requirements.
We turn Regulatory complexity into confident, compliant product launches worldwide.
ISO 14971 consulting includes:
Freyr’s pool of experts offers medical device risk management consulting services for planning risk management activities, establishing a risk management system, conducting gap analysis, ensuring compliance with the ISO 14971:2019 edition, and creating compliant risk management files.
ISO 14971 Risk Management Consulting
- Medical device risk management consulting.
- Transition from ISO 14971:2007 to ISO 14971:2019.
- In-depth gap analysis for current procedures and risk management documents.
- Preparation of a comprehensive remediation plan.
- Development of complete ISO 14971 medical device risk management documents and procedure systems.
- Support for individual critical elements of whole systems, such as risk analysis, Post-market Surveillance (PMS), etc.
- A qualified pool of experts with a focus on identifying and reducing risk in different types of devices.
- Experienced in executing multiple projects for the implementation of QSR, MDSAP, and ISO 13485 quality systems for a wide range of device classifications.
- In-depth knowledge of specific product categories, with a coverage of wide functional and technical aspects of devices, to support 360-degree coverage of risk assessment.
