ISO 14971
ISO 14971 is a key standard that provides a framework for risk analysis, evaluation, control, and review of medical devices including active, non-active, implantable, non-implantable, software as a medical device and in-vitro diagnostic medical devices. The framework systematically provides a means to integrate experience, insight, and judgment to manage the risks associated with the use of these devices. It also outlines procedures to review and monitor the effectiveness of the risk control measures during production and post-production stages.
Medical Device Services
In the fast-paced digital healthcare landscape, we help MedTech companies prioritize accurate diagnostics, treatment, and patient safety by applying ISO 14971 standard. Our services include:
Risk Management
We identify risk management activities for the medical device’s intended use, establish risk acceptability criteria and outline verification methods for risk control measures
Risk Assessment
We identify hazards using methods like PHA, FTA, and FMEA. We then assess risk by calculating the probability and severity of harm, followed by evaluating the overall residual risk against the device's intended benefits.
Risk Control Measures (RCM)
We define and implement Risk Control Measures (RCM) to lower inherent risks to acceptable levels, including verification of these measures.
Characteristics related to Safety
We assist the manufacturers in identifying qualitative and quantitative characteristics of medical devices that could affect their safety and define their limits
Supporting Activities
We assist in establishing a monitoring system for the medical device during production and post-production to collect information that may affect the benefit-risk analysis.
Audit Support
We prepare a comprehensive Risk Management file, including a Risk Management Plan and ISO 14971 Compliance Matrix, essential for certification by regulatory authorities like the Food and Drugs Administration (FDA)
Get in Touch
If you need expert guidance on applying ISO 14971 to your medical devices, contact us today. Learn more about our services and how we can help you manage risks effectively and efficiently.
Let us help you navigate the complexities of risk management in the medical device industry. We look forward to working with you!