A Review of Key Standards In Medical Devices Risk Management
As soon as its carried out you have to affirm and report the effectiveness of every single risk control measure. Medical device companies more likely than not should establish risk management processes that meet the standards of ISO 14971. What's more, it doesn't make a difference if you are making medical devices in the U.S., EU, Canada, Asia, etc. Any international regulatory agency you have heard about approves of ISO 14971
ISO 14971 is a gold standard. It is instructive and clear, simple enough to understands, but also, is the procurement risk management standard for the medical device industry.
Here is a short review of the standards including the key concepts of risk management for medical devices.
RISK ANALYSIS
Within ISO 1471, when reviewing the risk management process for medical devices manufacturers, the initial primary phase is risk analysis
Medical device risk management analysis is the analytical utilization of available data to identify Hazards, and to assess the risk. So as to do as such, you have to characterize the Scope of your medical device. You have to indicate the intended use of the product. Then, you begin to distinguish hazards and hazardous situations. As soon as the hazards and hazardous situations are outlined, you have to estimate risks.
Keep in mind, Risk combines the likelihood of occurrence of damage and the severity of that damage.
RISK = SEVERITY (S) x OCCURRENCE (O)
Nevertheless, to decipher this you have to evaluate the severity of damage that can result from hazards/hazardous situations. Then, you should gauge the likelihood of occurrences of each damage
RISK EVALUATION
Subsequent to gauging risk by defining severity and occurrence, you then have to assess the risks. Risk evaluation includes making decision about which risks are permissible and which are impermissible
RISK CONTROL
Risk controls are carried out as a strategy to decrease and mitigate impermissible risks. There are some options to think about when performing risk controls. By far the most common medical device risk management control measure, is to optimize product labeling. In any case, understand that labeling as a risk control is actually the least effective
Ideally, risk controls must be ascertained in accordance with following priorities
Product Design
Protective measures included within the medical device
Labeling, directions for usage
As soon as its carried out you have to affirm and report the effectiveness of every single risk control measure.
RESIDUAL RISK ASSESSMENT
Subsequent to affirming effectiveness of risk controls, next is to reevaluate the ensuing risks. Furthermore, if risks are still unpermissible, extra risk controls will be essential. Interestingly, as you carry out risk controls, you could be presenting new hazard and hazardous situations. These likely new hazards and hazardous situations additionally should be assessed and gauged
Finally, after each and every step has been addressed, they must be analyzed and documented within the procurement risk management report