In the Medical Device market, safety is defined as freedom from unacceptable risk.
Even regulatory agencies acknowledge that there is no such thing as a risk-free medical
device. Medical device manufacturers have to aim for safer medical devices which, in turn, result in fewer device recalls.
Risk Management is the process by which software risks are analyzed, evaluated, controlled
and monitored and it is the core of the development of any medical device. During the
development, this is mainly achieved by identifying and implementing risk control measures/mitigation activities (i.e. layers of safety) and verifying the effectiveness of these measures/activities.
When used effectively, risk management can direct the development effort towards the safety-critical areas of the device and can significantly help in the regulatory submissions.
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