#ISO 14971 ISO#
#ISO 14971 SERIES#

As such, these devices require regulatory scrutiny beyond that necessary for commercial electronic devices.

#ISO 14971 ISO#

ISO 14971: Risk Management for Medical DevicesР”Вue to the sensitive nature of their usage and the risks associated in the event of a failure, medical devices are classified as critical devices. This should be ongoing and the results used to improve the process.Р”Р‡ollowing the process above will assist you with the development of a well-founded risk management plan. The occurrences, responses and impacts of risks need to be monitored for effectiveness. The objective of risk planning is to devise a method to respond to a risk such that negative impacts are mitigated and positive impacts are enhanced. Although a risk may be identified, its impact may be deemed inconsequential or acceptable and not warranting a response. This is a critical step where you should rank the identified risks based on the severity of their impact on the activity. The first step in being able to mitigate a risk is to recognize it as a factor that may impact the activity.Р”Р‡ollowing the identification of a risk, it is necessary to determine how and to what degree it can impact the activity. For electronics device development, a good risk management process should include the following: The process of predicting, monitoring and analyzing factors (risks) that may have anР’В impact on some operation or function and identifying and implementing ways to control their impact.Р”Р„lthough risk management is often focused on minimizing financial losses, a risk may be any aspect of an activity, such as product development, which may impact the overall activity.

Risk management can be generally defined as: But before diving into a discussion about this standard, letРІР‚в„ўs first define risk management in general. And one standard, ISO 14971, explicitly targets risk management for medical devices. Medical device development is highly scrutinized and there are many regulations and standards that developers, suppliers, distributors and other service providers must follow. This is especially true when the risks can lead to severe outcomes, such as injury or even fatality, as is the case when designing and developing medical devices. Consequently, risk management is a major concern for any organization. Risks are distinct threats that can positively or negatively impact our endeavors.

Risk is not just a philosophical concept. Assuming risks do exist and our choices can increase or decrease the probability of their manifestation, it behooves us to try and manage them to improve our life experience and ward off possible catastrophes. Have you ever tried crossing a busy street without traffic light assistance? Not surprisingly, that can be a rather terrifying experience. Yet, careful observation appears to support that life is definitely filled with risks of varying degree.

#ISO 14971 SERIES#

At times, a series of events can certainly seem to give credence to the latter position.

A formidable philosophical debate that I have engaged in with more than one willing participant is whether life poses any true risks or if we are simply fulfilling predetermined destinies.

Iso 14971