ISO14971 Medical Device Risk Management Requirements

   Meets risk management requirements for medical devices

ISO14971 Medical Devices – Application of Risk Management for Medical Devices details the risk management principles and practices mentioned in several major medical device standards, including IEC60601-1 3rd Edition (Electrical Safety), ISO13485 (Quality Management System), IEC / EN 62366 (availability of medical devices), ISO10993 (biological evaluation) and IEC62304 (medical device software). Therefore, compliance with ISO 14971 is fundamental to medical device manufacturers seeking regulatory licenses in the US, EU, Japan, Australia and other major international markets.

   The risk management process described in ISO 14971 includes:

  1) Identify hazards and hazardous conditions associated with medical devices that may pose risks to patients or healthcare workers;

  2) Evaluate the potential for the occurrence of such risks, and evaluate the severity of the consequences;

  3) To control risks, establish and implement positive protective measures in the device or production process;

  4) Periodically review and monitor processes to assess the effectiveness of risk management controls and risk management processes

  Use ISO14971 standard to control risk

   As we all know, risk consists of two parts: (1) the probability of harm occurring, that is, the frequency with which the harm may occur; (2) the consequences of the harm, that is, the severity of the harm.

   The extent to which stakeholders are able to tolerate risk is influenced by the above two factors and their perception of risk. These concepts are especially important when it comes to medical devices, as stakeholders involve multiple parties—physicians, healthcare organizations, government agencies, industry organizations, patients, and the public.

As one of the stakeholders, the manufacturer should make some judgments about the safety of the medical device—including its level of risk acceptance, taking into account the state of the art in accepted technology—in order to determine when placing the medical device on the market for intended use whether it is likely to be suitable for the purpose or intended purpose. This International Standard specifies a set of procedures by which manufacturers of medical devices can identify hazards associated with medical devices, assess the risks associated with those hazards, control those risks and monitor the effectiveness of the controls.

   For any particular medical device, other international standards may require the application of specific methods to control risk.

   Each aspect of the risk management system is documented in detail and used to demonstrate the manufacturer's commitment to controlling the occurrence of risks throughout the design of a particular medical device.

   A robust risk management system can also support the development, production and distribution of new medical devices of all types, thereby creating significant value. Products under development require more monitoring in the early design stages. Changes and revisions are thus identified and implemented to improve functional safety and usability with minimal impact on product development schedules. For certain types of medical devices, an effective risk management evaluation will also identify risks associated with device reprocessing and reuse. These and other benefits will help speed time to market and increase competitive advantage.