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ISO 14971 Risk Management Consulting
ISO 14971 is acknowledged worldwide as the definitive standard for medical device risk management, with formal recognition from leading regulatory bodies including the United States Food and Drug Administration (US FDA), Health Canada (HC), Australia’s Therapeutic Goods Administration (TGA), Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), and the European Medicines Agency (EMA). At Pharma Wizard, our ISO 14971 risk management consulting empowers medical device manufacturers to align seamlessly with these global regulatory expectations, ensuring compliance, safety, and market readiness across multiple jurisdictions.
ISO 14971 Risk Management Consulting – Overview
The ISO 14971 standard has been formally recognized as the risk management benchmark for medical devices by the United States Food and Drug Administration (US FDA), Health Canada (HC), the Therapeutic Goods Administration (TGA) in Australia, and the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan. It is also a harmonized standard within the European Union (EU) and forms an essential part of risk management systems aligned with ISO 13485.
Revised in 2019, the third edition requires manufacturers to update their existing risk management systems and documentation to ensure compliance.
ISO 14971 outlines the terminology and processes for risk management applicable to medical devices, Software as a Medical Device (SaMD), and in vitro diagnostics (IVDs). It guides manufacturers in identifying hazards, assessing and evaluating the associated risks, implementing appropriate risk controls, and monitoring the effectiveness of those controls throughout the product lifecycle.
ISO 14971 consulting includes:
- Risk management process.
- Assigning qualified personnel.
- Establishing a risk management framework.
- Undertaking risk analysis and estimating the risk for each hazardous situation.
- Evaluating the risk for each identified hazardous situation.
- Developing risk control measures when risk must be reduced.
- Evaluating the acceptability of the overall residual risk.
- Carrying out a risk management review and preparing a risk management report.
- Establishing a monitoring system for the production and post-production phases.
Pharma wizard 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
- Expertise
- Advantages
- 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.
