ISO 14971 provides a framework for the risk management of medical devices, including active, non-active, implantable, non-implantable, software as a medical device, and in-vitro diagnostic devices.
This framework integrates experience, insight, and judgment to manage device risks and outlines procedures to review and monitor the effectiveness of risk control measures during production and post-production.
What we offer ?
Risk Management
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Identification of risk management activities for the medical device’s use.
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Establish risk acceptability criteria and outline verification methods for risk control measures.
Risk Assessment
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Identification of hazards using tools like PHA, and FMEA.
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Assess risk by calculating the probability and severity of harm, evaluating the overall residual risk against the device's benefits.
Risk Control Measures (RCM)
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Define and implement RCMs to lower inherent risks to acceptable levels.
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Verification activities of RCMs.
Characteristics related to Safety
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Assist the manufacturers in identifying qualitative and quantitative characteristics of medical devices that affect their safety and define their limits.
Supporting Activites
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Establish a monitoring system for the medical device during production and post-production to collect information that may affect the benefit-risk analysis.
Audit Support
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Prepare a comprehensive Risk Management file, including a Risk Management Plan and ISO 14971 Compliance Matrix, for certification by authorities like the Food and Drugs Administration (FDA)
How to collaborate?
Safety Assessments
Our expertise in medical risk assessments helps your organization and product development to ensure that devices meet rigorous safety standards and regulations.
Safety Training (ISO 14971)
Our training program is tailored to deliver practical knowledge of how to conduct Risk Management, Risk Assessment, RCMs for application of risk assessments in medical device development.
The Safety Gazette
