Risk Management Plans

Risk management is an essential part of all your company’s processes. Recently redefined in ISO 14971, you will find the international requirements of risk management systems for medical devices which also defines best practices throughout the entire life cycle of a device. To ensure  safe and effective product entries to the market, a risk management plan and system has become imperative.

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Integrating risk management effectively during the design phase requires its implementation during the during early phases of development and precedes your trials. The post-marketing activities include a well-established, documented and sustained process that allows you to estimate and evaluate the associated risks, to control these risks, and monitoring the effectiveness of the controls that you put in place.