Risk Management is your system of management policies, procedures, analysis practices, and monitoring risk.  An effective risk management program is an essential element in the life cycle of a medical device.    

A Hazard is a potential source of harm.  A Risk is your estimated probability that a Hazard occurs for your medical device and the severity of that Hazard to patients, users, etc.  So, how do you do risk management?  You start with ISO 14971.

ISO 14971 is the International Standard that specifies terminology, principles and a process for risk management of medical devices, software as a medical device, and in-vitro diagnostic medical devices. 

The ISO 14971 process will help you identify the risks associated with your medical device, to estimate and evaluate the risks, the measures you use to control these risks, and to monitor the effectiveness of your controls.  Your risk management process applies to the full spectrum of risks including, but not limited to  biocompatibility, data and systems security, electricity, moving parts, radiation, maintenance, calibration, transport, and usability.  ISO 14971 does not specify acceptable risk levels.  You set objective criteria for risk acceptability and you set the acceptable risk levels.

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Remember, an effective risk management program isn’t just a one-time exercise, it is an ongoing part of your product life cycle. Effective risk management helps you protect your patients, your products, and your reputation.

ISO has recently updated ISO 14791 with ISO/TR 24971:2020.  This technical report includes additional guidance on the principles and the process for managing risks associated with software as a medical device (SaMD) and in-vitro diagnostic (IVD) medical products.  You want to review and update your risk management process to apply the principles in ISO 14971 and technical report ISO/TR 24971 to make your risk management program optimally effective.

PSC Biotech® has experienced risk management professionals who can help you establish your program and provide risk management services tailored to your needs.  Call us today and let’s talk about effective risk management.

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